PlainRecalls

Abbott Gmbh & Co. Kg

Compiled from official public sources by the publisher.

19 recalls on record · Latest: Aug 5, 2020

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Agency notice ledger

Federal filing book Abbott Gmbh & Co. Kg LIGHT-BOOK · SINGLE-AGENCY

#827 of 14,151 · 19 notices · 0.018% archive

  • BOOK 19 notices
  • RANK #827 of 14,151
  • SHARE 0.018% archive
  • AGENCY FDA Devices (19)
  • CAT medical devices
  • CATS 1 category
  • LATEST Aug 5, 2020
  • PHOTO Abbott

Nearest notice-volume peer: Abbott (0 notice gap)

Abbott Gmbh & Co. Kg accounts for about 0.018% of the 104,423-notice archive on 19 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 →

Where Abbott Gmbh & Co. Kg sits among 14,151 recalling firms

Abbott Gmbh & Co. Kg ranks 827th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Abbott Gmbh & Co. Kg vs all firms by recall-notice count

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

19 827th of 14151 higher than 13,281 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

Abbott Gmbh & Co. Kg in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Abbott Gmbh & Co. Kg holds about 0.018% of archive notices alongside 19 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Aug 5, 2020

Alinity ci series System Control Module (SCM); LN 3R70-01 Alinity ci series software versions, 3.1.1 and below
FDA Devices Moderate Jun 24, 2020

Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics.
FDA Devices Moderate Jun 3, 2020

ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to help ensure appropriate therapy.
FDA Devices Moderate Apr 29, 2020

ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.
FDA Devices Moderate Apr 1, 2020

LN 3R70-01; software version 2.6.2 and earlier. The software is used with the Alinity i (LN 03R65-01) processing module and the Alinity c (LN 03R67-01) processing module.
FDA Devices Moderate Dec 4, 2019

ARCHITECT HAVAB-G Calibrator, REF 6L27-01
FDA Devices Moderate Dec 4, 2019

Accessory kit, Alinity i containing Alinity ci Level Sensor, Bulk Solution
FDA Devices Moderate Dec 4, 2019

Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I. Inc. Prince Edward Island Canada
FDA Devices Moderate Dec 4, 2019

Alinity ci Level Sensor, Bulk Solution
FDA Devices Moderate Dec 4, 2019

Accessory kit, Alinity c containing Alinity ci Level Sensor, Bulk Solution
FDA Devices Moderate Sep 4, 2019

Alinity ci -series System Control¿Module, Part Number 03R70 01 Product Usage: The Alinity ci series System Control Module has a scalable design to provide full integration of clinical chemistry and immunoassay analysis. The Alinity ci series System Control Module includes a clinical chemistry module and an immunoassay module, each performing all sample processing activities, and a system control module to provide a single user friendly interface. Each system can be customized by combining on
FDA Devices Moderate Aug 14, 2019

The Alinity ci-series System Control Modules which are configured with Alinity c Processing Modules. The Alinity ci-series Control Module is labeled in part,"* * *Alinity ci-series* * *SYSTEM CONTROL MODULE Product Usage: The Alinity ci series System Control Module has a scalable design to provide full integration of clinical chemistry and immunoassay analysis. The Alinity ci series System Control Module includes a clinical chemistry module and an immunoassay module, each performing all sam
FDA Devices Moderate Jun 12, 2019

Alinity c Cuvette Segments, List Number 04S47-01 Product Usage: The Alinity c Cuvettes are used on the Alinity c system processing module. The Alinity c processing module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology.
FDA Devices Moderate Jun 5, 2019

Alinity i Processing Module, 03R65 01, with the below components. a. TED (Thermo Electric Device) Engine, Reagent cooler; b. CABLE, POWER OUT, TED CNTRLER Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analy
FDA Devices Moderate May 22, 2019

Abbott Alinity ci-series System Control Module software version 2.5.1; LN 3R70-01 with the following hardware: Level Sensor, Bulk Solution; 04S68-01, Accessory Kit, Alinity I; 03R66-01and 03R66-02 , and Accessory Kit, Alinity c; 03R69-01 and 03R69-02. Product Usage: The Alinity i (LN 03R65 01) processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoas
FDA Devices Moderate Apr 24, 2019

Abbott Alinity c Processing Module LN 03R67-01 - Product Usage: The Alinity c processing module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology. The Alinity c processing module uses photometric detection technology to measure sample absorbance for the quantification of analyte concentration and uses potentiometric detection technology to measure the electri
FDA Devices Moderate Apr 24, 2019

Abbott Alinity i Processing Module LN 03R65-01 - Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples.
FDA Devices Moderate Feb 6, 2019

Alinity i Processing Module, (a) Part Number 03R65-01 (b) Part Number A-30108552-01 (c) Part Number A-30109694-01 Product Usage: The Alinity i processing module is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analytes in samples.
FDA Devices Moderate May 16, 2018

ARCHITECT DHEA-S Reagent Product Usage: It is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of dehydroepiandrosterone sulfate (DHEA-S) in human serum and plasma on the ARCHITECT iSystem.

Abbott Gmbh & Co. Kg holds a measurable archive slice

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.

Abbott 19 Abbott Medical Optics Inc. (Amo) 19 Amo Puerto Rico Manufacturing, Inc. 19 Applied Medical Technology Inc 19

Frequently Asked Questions

How many federal recall notices name Abbott Gmbh & Co. Kg? ▼
PlainRecalls indexes 19 distinct federal recall events naming Abbott Gmbh & Co. Kg, 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 Abbott Gmbh & Co. Kg sit among other recalling firms? ▼
Abbott Gmbh & Co. Kg ranks #827 of 14,151 by distinct recall-event count among 14,151 firms in this archive (94th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Abbott Gmbh & Co. Kg's notices? ▼
FDA Devices accounts for 19 of this firm's 19 indexed notices.
What product category dominates Abbott Gmbh & Co. Kg's filing book? ▼
Filings for Abbott Gmbh & Co. Kg 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.
Abbott Gmbh & Co. Kg: 19 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 Abbott Gmbh & Co. Kg; individual notices remain authoritative on each linked recall page.

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