PlainRecalls

Roche Diagnostics Operations, Inc.

Compiled from official public sources by the publisher.

127 recalls on record · Latest: Mar 11, 2026

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Agency notice ledger

Federal filing book Roche Diagnostics Operation… HEAVY-BOOK · SINGLE-AGENCY

#126 of 14,151 · 127 notices · 0.122% archive

  • BOOK 127 notices
  • RANK #126 of 14,151
  • SHARE 0.122% archive
  • AGENCY FDA Devices (127)
  • CAT medical devices
  • CATS 1 category
  • LATEST Mar 11, 2026
  • PHOTO Philips North America

Nearest notice-volume peer: Philips North America (1 notice gap)

Roche Diagnostics Operations, Inc. accounts for about 0.122% of the 104,423-notice archive on 127 distinct filings — a heavy share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Roche Diagnostics Operation…'s standing among 14,151 recalling firms

Roche Diagnostics Operations, Inc. ranks 126th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Roche Diagnostics Operation… vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

127 126th of 14151 higher than 14,025 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Roche Diagnostics Operation… in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Roche Diagnostics Operations, Inc. holds about 0.122% of archive notices alongside 127 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Mar 11, 2026

cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number 08464502001 cobas pro SSU, material number 09205632001 Affected Assays: (Product Name/ Catalog Number/ Application Code/ Application Short Name) 1. Cystatin C Gen.2 08105596190 20510 CYSC2 2. Ferritin Gen.4 08057648190 20571 FER4X 3. Lipoprotein (a) Gen.2 08106126190 20861 LPA2X 4. Lipoprotein (a) molarity 08106126160 20864 LPA2-X 5. Vancomycin Gen.3 08058849190 21211

FDA Devices Moderate Jan 14, 2026

The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and electrochemiluminescence detection. Patient serum sample is incubated with pretreatment reagent PT1 and the reconstituted PT2 containing a pre-formed immunocomplex of solubilized porcine TSH receptor (pTSHR) and biotinylated anti-pTSHR mouse monoclonal antibody.
FDA Devices Moderate Nov 27, 2024

cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine
FDA Devices Moderate Oct 2, 2024

Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative determination of creatine kinase (CK) in human serum and plasma. Catalog Number: 07190794190
FDA Devices Moderate Nov 29, 2023

Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311, 501 and 502; INTEGRA 400 plus), 08105618190 - (cobas c 303 and 503)
FDA Devices Moderate Jan 18, 2023

cobas infinity central lab, Material Number 07154003001
FDA Devices Moderate Aug 17, 2022

cobas e801 Immunoassay Analyzer
FDA Devices Moderate Nov 24, 2021

Cobas u 601 urinalysis test system, Catalog number 06334601001 The cobas U 601 urinalysis test system is comprised of the cobas u 601 urine analyzer and the cobas u pack. The cobas u 601 urine analyzer when used with the cobas u pack is a fully automated urinalysis system intended for the in vitro qualitative or semi-quantitative determination of urine analytes, including pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin, color and erythrocytes, as well as clarity.
FDA Devices Moderate Sep 22, 2021

cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001
FDA Devices Moderate Jun 2, 2021

IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 03183696122 - Product Usage: In vitro test for the quantitative determination of iron in human serum and plasma on Roche/Hitachi cobas c and cobas Integra systems.
FDA Devices Moderate May 26, 2021

Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.
FDA Devices Moderate May 26, 2021

Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.
FDA Devices Moderate Feb 17, 2021

9180 Electrolyte Analyzer - Product Usage: intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and lithium in the whole blood, serum or plasma, urine, dialysate solutions, or QC materials. catalog number 03157334001 . in vitro diagnostic use.
FDA Devices Moderate Jan 27, 2021

A calculator/data processing module for clinical use is an electronic device intended to store, retrieve, and process laboratory data Catalog Number: 07154003001
FDA Devices Moderate Jan 13, 2021

CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin or warfarin. Catalog 04837738001
FDA Devices Moderate Jan 13, 2021

CoaguChek XS Prof (Professional) Meters- IVD professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. Catalog: 04837975001 Units could consist of any of the following strip configurations: 6 count, 24 count, 2x 24 count (i.e. 48 strips)* *CoaguChek XS 3x48 promo LTC HH Catalog: 06298176001 CoaguChek XS 6x24 promo LTC HH Catalog:08468699001 CoaguChek XS 4x48 promo Catalog: 08468745001 CoaguChek XS 6x48 promo

FDA Devices Moderate Jan 6, 2021

cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinical use
FDA Devices Moderate Jan 6, 2021

Roche cobas pro integrated solutions (cobas pro ISE, cobas c 503, and cobas e 801 analytical units) Chemistry Analyzer (photometric discrete), for clinical use Part Number: 05641446001
FDA Devices Moderate Jan 6, 2021

Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001
FDA Devices Moderate Dec 23, 2020

Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 - Product Usage: the in vitro quantitative determination of CRP in human serum and plasma on Roche automated clinical chemistry analyzers.
FDA Devices Moderate Nov 25, 2020

cobas infinity central lab/cobas infinity core license-The cobas infinity IT solutions application is intended to be used for the configuration and connectivity management of instruments and software systems Catalog Number: 07154003001
FDA Devices Low Oct 21, 2020

Albumin Gen.2, Catalog 05166861190
FDA Devices Low Oct 21, 2020

Tina-quant Complement C4 ver.2, Catalog 05991994190
FDA Devices Moderate Oct 14, 2020

DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only) Material Number: 05987750001
FDA Devices Moderate Oct 14, 2020

BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001
FDA Devices Moderate Sep 23, 2020

Elecsys Anti-TPO Assay on cobas e analyzers 411, 601, 602, Catalog Number 06368590190
FDA Devices Moderate Mar 11, 2020

Elecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for monitoring and management of pancreatic cancer
FDA Devices Moderate Feb 19, 2020

cobas infinity core, Material No. 7154003001. The device is a calculator/data processing module, for clinical use.
FDA Devices Moderate Feb 5, 2020

Cobas infinity central lab / cobas infinity core license-a Calculator/Data Processing Module, For Clinical Use Material Number: 07154003001
FDA Devices Moderate Dec 25, 2019

Roche Homocysteine-In vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c systems Catalog Number: 06542921190 - - Product Usage: The assay can assist in the diagnosis of patients suspected of having hyperhomocysteinemia or homocystinuria.
FDA Devices Moderate Dec 18, 2019

Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma Catalog number: 07026773190
FDA Devices Low Oct 23, 2019

Roche Diagnostics cobas Integra Albumin Gen.2 Catalog Number: 05166861190 - Product Usage: In vitro test for the quantitative determination of the albumin in human serum and plasma on Roche/Hitachi cobas c systems.
FDA Devices Low Oct 23, 2019

Cobas c Bilirubin Total Gen.3 Catalog Number: 05795419190 - Product Usage: In vitro test for the quantitative determination of the total bilirubin in serum and plasma of adults and neonates on Roche/Hitachi cobas c systems.
FDA Devices Moderate Oct 16, 2019

Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c 311 and cobas c 501/502
FDA Devices Moderate Oct 16, 2019

cobas c 701 and 702 Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 05950821190
FDA Devices Moderate Oct 16, 2019

AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000 MODULAR Analyzer Series (IVD for in vitro determination of analytes in human body fluids) Catalog Number: 5694302001
FDA Devices Moderate Oct 16, 2019

Online TDM Vancomycin Gen.3 ( 200 tests) Catalog # 06779344190 Analyzer/Module: cobas c 311 and cobas c 501/502
FDA Devices Moderate Oct 16, 2019

cobas c 311; cobas c 501, 502,and COBAS INTEGRA 400 plus Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 20763454122
FDA Devices Moderate Sep 11, 2019

cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001
FDA Devices Moderate Sep 11, 2019

The Tina-Quant Myoglobin Gen. 2 Tests system is an immuno-turbidimetric assay for the quantitative in vitro determination of myoglobin in human serum and plasma on Roche automated clinical chemistry analyzers
FDA Devices Moderate Sep 11, 2019

cobas c513 Analyzer
FDA Devices Moderate Sep 11, 2019

Cobas 8000 Modular Analyzer Series: cobas 8000 ISE module part Numbers : 05964075001 cobas c 701 module part Numbers : 05641489001 cobas c 702 module part Numbers : 06473245001
FDA Devices Moderate Sep 4, 2019

Roche Elecsys Anti-CCP Immunoassay Catalog # 05031656160
FDA Devices Moderate Sep 4, 2019

Roche Elecsys Anti-CCP Immunoassay Catalog # 07251670190
FDA Devices Moderate Feb 1, 2017

Tina-Quant (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive) The Tina-Quant CRP (Latex) High Sensitive Immunoturbidimetric assay is for the in-vitro quantitative determination of C-reactive protein (CRP) in human serum and plasma on Roche automated clinical chemistry analyzers. Highly sensitive measurement of CRP is of use for the detection and evaluation of inflammatory disorders, and associated diseases, infection and tissue injury. Measurement of CRP may also be used as an

FDA Devices Moderate Feb 1, 2017

Cobas b 123 POC system The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes Nat, K+, iCaWt (ISE), hematocrit (THct), metabolites (Glu, Lac), total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHb, COT~b, MetHb), and oxygen saturation (SO2). In addition, the cobas b 123 POC system calculates derived parameters. It is dedicated for use in a Point-of-Care environment and laboratory. The integrated AutoQC module an
FDA Devices Moderate Dec 7, 2016

MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the Roche OMNI S Analyzer: cobas b 221<6>Roche OMNI S6 system The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solut
FDA Devices Moderate Nov 23, 2016

COBAS INTEGRA 800 Tina-Quant Hemoglobin A1cDX Gen.2 Hemoglobin A1cDX test Catalog number 04528123160
FDA Devices Moderate Nov 23, 2016

Tina-Quant Hemoglobin A1c Gen. 2 Hemoglobin A1c test Catalog number 04528123190 / 05401640190
FDA Devices Moderate Nov 16, 2016

Roche COBAS INTEGRA c111 Analyzer, Chemistry (Photometric, Discrete), for clinical use Product Usage: The Roche COBAS INTEGRA c111 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically. The analyzer also has an optional ISE module for measuring sodium, potassium and chloride.

Roche Diagnostics Operation… carries an outsized archive share

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Philips North America 126 Abbott Laboratories 124 Covidien, LP 131 Philips Ultrasound, Inc 132

Frequently Asked Questions

How many federal recall notices name Roche Diagnostics Operation…? ▼
PlainRecalls indexes 127 distinct federal recall events naming Roche Diagnostics Operations, Inc., aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Roche Diagnostics Operation… sit among other recalling firms? ▼
Roche Diagnostics Operations, Inc. ranks #126 of 14,151 by distinct recall-event count among 14,151 firms in this archive (99th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Roche Diagnostics Operation…'s notices? ▼
FDA Devices accounts for 127 of this firm's 127 indexed notices.
What product category dominates Roche Diagnostics Operation…'s filing book? ▼
Filings for Roche Diagnostics Operations, Inc. span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Roche Diagnostics Operations, Inc.: 127 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Roche Diagnostics Operations, Inc.; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026