Roche Molecular Systems, Inc.
42 recalls on record · Latest: Feb 15, 2023
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Agency notice ledger
Federal filing book Roche Molecular Systems, In… MID-BOOK · SINGLE-AGENCY
#418 of 14,151 · 42 notices · 0.040% archive
- BOOK 42 notices
- RANK #418 of 14,151
- SHARE 0.040% archive
- AGENCY FDA Devices (42)
- CAT medical devices
- CATS 1 category
- LATEST Feb 15, 2023
- PHOTO Apotex Inc.
Nearest notice-volume peer: Apotex Inc. (0 notice gap)
Roche Molecular Systems, Inc. accounts for about 0.040% of the 104,423-notice archive on 42 distinct filings — a mid 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 Molecular Systems, In…'s standing among 14,151 recalling firms
Roche Molecular Systems, Inc. ranks 418th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.
Roche Molecular Systems, In… vs all firms by recall-notice count
Where this firm's archive sits among every tracked recalling manufacturer
42 418th of 14151 higher than 13,732 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 Molecular Systems, In… in the notice-volume neighbourhood
Distinct federal recall events among this firm and nearest nationwide peers
- Roche Molecul… (this)
Roche Molecular Systems, Inc.
42 notices
- Apotex Inc.
Apotex Inc.
42 notices
- Cardinal Heal…
Cardinal Healthcare
42 notices
- Exp Pharmaceu…
Exp Pharmaceutical Services Corp
42 notices
- Frito Lay Inc
Frito Lay Inc
42 notices
- Lexus
Lexus
42 notices
What this shows Roche Molecular Systems, Inc. holds about 0.040% of archive notices alongside 42 distinct filings.
FDA Devices Moderate Feb 15, 2023
cobas SARS-CoV-2 & Influenza A/B Qualitative nucleic acid test for use on the cobas 5800/6800/8800 Systems; Material Number 09446125190
FDA Devices Moderate Feb 15, 2023
cobas Influenza A/B & RSV UC (Utility Channel) Qualitative nucleic acid test for use on the cobas 6800/8800 Systems; Material number 09233962190
FDA Devices Moderate Feb 15, 2023
cobas SARS-CoV-2 & Influenza A/B Qualitative assay for use on the cobas 6800/8800 Systems; Material number 09233474190
FDA Devices Moderate Oct 26, 2022
cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) in laboratory settings.
FDA Devices Moderate Apr 6, 2022
cobas LiatSystem, respiratory virus panel nucleic acid assay system, Material Number 07341920190
FDA Devices Moderate Oct 20, 2021
cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
FDA Devices Moderate Sep 29, 2021
cobas SARS-CoV-2 & Influenza A/B Test for use on the cobas Liat System, Catalog Number 09211101190
FDA Devices Moderate Apr 21, 2021
cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190
FDA Devices Moderate Apr 21, 2021
cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus Nucleic Acid for use on the cobas Liat System, Catalog Number: 09211101190
FDA Devices Moderate Jan 27, 2021
uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001
FDA Devices Moderate Jan 20, 2021
The cobas z 480 analyzer including dedicated software for IVD use is a plate-based automated amplification and detection system for nucleic acids. The analyzer is intended to be used as an in-vitro diagnostic or screening system providing real time PCR amplification and detection for human samples within the system. The cobas x 480 instrument and cobas z 480 analyzer are to be used by laboratory professionals trained in laboratory techniques and by instruction on the use of the system and ana
FDA Devices Moderate Jul 22, 2020
MagNA Pure 96 Instrument, clinical sample concentrator, Material number 06541089001 - Product Usage: This protocol is intended for pipetting samples into a MagNA Pure 96 Processing Cartridge (purification rack position 1) before a purification run.
FDA Devices Moderate Jun 6, 2018
MagNA Pure 24 System, GMMI: 07290519001 Product Usage: The MagNA Pure 24 System is a fully automated clinical sample extractor. It extracts nucleic acids from various sample types, sample tubes, and volume inputs for multiple downstream applications. The main features of the system are : Scalable purification of 1 to 24 samples Primary/secondary tube handling Inventory and sample management via barcodes Efficient order management via host The MagNA Pure 24 System offers 4 run types:
FDA Devices Moderate Apr 4, 2018
Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic.
FDA Devices Moderate Dec 21, 2016
LightMix¿ Zika rRT-PCR Test The LightMix¿ Zika rRT-PCR Test is a real-time RT-PCR test intended for the qualitative detection of RNA from the Zika virus in serum or EDTA plasma from individuals meeting CDC Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiologic crit
FDA Devices Moderate Jul 27, 2016
cobas¿ Liat¿ Analyzer
FDA Devices Moderate Jul 27, 2016
cobas EGFR Mutation Test V2 Materials number CE-IVD: EGFR v2: 07248563190 cfDNA: 07247737190 Device Identifier: EGFR v2.0: 00875197005448 cfDNA: 00875197005424 Product Usage: A real time PCR Test for the qualitative detection and identifications of mutations n exons 18, 19, 20 and 21 of the epidermal growth factor receptor (EGFR) gene in DNA derived from formalin-fixed paraffin-embedded (FFPET) tumor tissue or plasma from non-small cell lung cancer (NSCLC) patients. The test also is
FDA Devices Low Jul 20, 2016
cobas¿ Liat Influenza A/B Quality Control Kit; For use with cobas¿ Liat Influenza A/B Assay.
FDA Devices Moderate Jun 1, 2016
cobas¿ EGFR Mutation Test, v2 and cobas¿ cfDNA Sample Preparation Hungarian Translation Instructions for Use
FDA Devices Moderate May 4, 2016
Hand-Held Scanner USB IT3800 For sample identification and tracking when used with various systems
FDA Devices Moderate Sep 9, 2015
cobas Liat Analyzer, for in vitro diagnostic use.
FDA Devices Low Apr 1, 2015
cobas¿ EGFR Mutation Test epidermal growth factor receptor (EGFR) gene DNA assay
FDA Devices Low Jan 28, 2015
cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test; CE-IVD 5852170190. Intended for the identification of mutations in codons 12,13 and 61 of the KRAS Gene in DNA derived from formalin-fixed paraffin-embedded human colorectal and non-small cell lung cancer tissues.
FDA Devices Moderate Mar 5, 2014
cobas¿ PCR Urine Kit 100 PKT IVD cobas¿ PCR Female Swab Kit 100 PKT IVD cobas¿ PCR media 100T IVD cobas¿ PCR Female Swab Kit 100 PKT JPN-IVD Roche Molecular Systems, Inc. Branchburg, NJ 08876 USA Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 The cobas¿¿ PCR media serves as a nucleic acid stabilizing transport and storage medium for gynecological specimens and is contained in the cobas¿¿ PCR Female Swab Kit, cobas¿¿ PCR Urine kit, and cobas¿¿ PCR media 100 T kit. -The
FDA Devices Moderate Sep 18, 2013
KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVD Roche Molecular System, Inc. 1080 US highway 202 South Branchburg, NJ 08876 USA Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 USA The cobas¿ HPV Test is a qualitative in vitro test for the detection of Human Papillomavirus in patient specimens. The test utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of 14 high-risk (HR) HPV types in a single ana
FDA Devices Moderate May 29, 2013
cobas¿ 4800 system z480 instrument. Integrates fully automated total nucleic acid isolation directly from secondary sample tubes.
FDA Devices Moderate Feb 6, 2013
COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE.
FDA Devices Moderate Jan 2, 2013
COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Automated sample processing instrument used with CAP/CA and CAP/CTM. Roche Molecular Systems, Inc. 1080 US Highway 202 South Branchburg, NJ 08876 USA Made in Switzerland
FDA Devices Moderate Dec 19, 2012
DataCare POC is an information management system that provides data management functionality for managing point-of -care testing data.
FDA Devices Moderate Dec 19, 2012
The MagNA Pure 96 System (versions 1.0 and 2.0) is a sample preparation instrument for automated isolation of nucleic acids in various types of biological materials. This is a general purpose instrument. There are no corresponding assays.
FDA Devices Moderate Dec 19, 2012
LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid), as well as post-PCR analysis of the amplified NA by melting curve analysis with corresponding assays.
FDA Devices Moderate Dec 19, 2012
LightCycler 2.0 Instrument (software version 4.1) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid), as well as post-PCR analysis of the amplified NA by melting curve analysis.
FDA Devices Moderate Dec 19, 2012
The MagNA Pure LC (version 3.0) is a sample preparation instrument that can be used with the LightCycler instrument for automated isolation of nucleic acids in various types of biological materials.
FDA Devices Moderate Dec 19, 2012
DataInnovations (Instrument Manager) (version 8.04) interfaces middleware between larger Clinical Chemistry / Immunology instrument systems and LIS systems.
FDA Devices Moderate Dec 19, 2012
Data Station AMPLILINK software is an instrument user interface/ data management software used with COBAS¿ AmpliPrep instrument, COBAS¿ TaqMan¿ analyzer, COBAS¿ TaqMan¿ 48 analyzer, COBAS¿ AMPLICOR¿ analyzer, and Cobas p 630 instrument for sample preparation, amplification and detection of PCR (Polymerase Chain Reaction) molecular diagnostic analytes.
FDA Devices Moderate Dec 19, 2012
The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully automated, computerized chemistry analyzer. It is intended for in vitro quantitative or qualitative determination of a wide range of analytes in various body fluids.
FDA Devices Moderate Dec 19, 2012
The COBAS 8000 data manager modular analyzer series (all versions) is a is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in-vitro determinations using a wide variety of tests.
FDA Devices Moderate Dec 19, 2012
DataCara GM is an information management system that provides data management functionality for managing blood glucose testing data.
FDA Devices Low Nov 7, 2012
cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecular Systems, Inc., Product Usage: The primary use of the cobas 4800 BRAF V600 Mutation Test is the detection of the BRAF V600 mutations in DNA extracted from formalin-fixed, paraffin-embedded human melanoma tissue. It is intended to be used as an aid in selecting melanoma patients whose tumors carry BRAF V600 mutations for treatment with Zelboraf (vemurafenib).
FDA Devices Moderate Sep 26, 2012
Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS TaqMan. The software can be used with a Laboratory Information System.
FDA Devices Moderate Aug 22, 2012
COBAS AmpliPrep Sample Tube Input Barcode Clips, catalog number 03137040001. Input S-tube barcode clips hold sample input tubes in the COBAS AmpliPrep Instrument (CAP) sample racks and have a barcode to identify the sample.
FDA Devices Low Aug 15, 2012
Cobas KRAS Mutation Test for In Vitro Diagnostic Use Product Usage: Usage: The Cobas KRAS Mutation Test, for use with the Cobas 4800 System, is a real-time PCR test intended for the identification of mutations in codons 12, 13 and 61 of the KRAS gene in DNA derived from formalin-fixed paraffin-embedded human colorectal cancer (CRC).
Roche Molecular Systems, In… holds a measurable archive slice
Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.
Similar recall count
Nearest multi-notice firms by distinct-event totals (42 here — heavy-book).
Similar medical devices volume
Nearest multi-notice firms in the same narrow category lane.
Frequently Asked Questions
How many federal recall notices name Roche Molecular Systems, In…? ▼
PlainRecalls indexes 42 distinct federal recall events naming Roche Molecular Systems, 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 Molecular Systems, In… sit among other recalling firms? ▼
Roche Molecular Systems, Inc. ranks #418 of 14,151 by distinct recall-event count among 14,151 firms in this archive (97th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Roche Molecular Systems, In…'s notices? ▼
FDA Devices accounts for 42 of this firm's 42 indexed notices.
What product category dominates Roche Molecular Systems, In…'s filing book? ▼
Filings for Roche Molecular Systems, 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 Molecular Systems, Inc.: 42 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 Molecular Systems, Inc.; individual notices remain authoritative on each linked recall page.
Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026