Abbott Gmbh & Co. KG: FDA recalls

FDA enforcement events from 2017 to 2020; export dated 3 Nov 2026. The recall start date and FDA report date are separate fields. Read the recall classes.

FDA enforcement reports name Abbott Gmbh & Co. KG as the recalling firm in 16 events. The events have 19 product records. The recalls started from 2017 to 2020. All the events are device recalls. By FDA enforcement events, Abbott Gmbh & Co. KG is number 218 of 1,628 firms that have a page. Events that Abbott Gmbh & Co. KG started: none in 2024 and none in 2025. For all FDA enforcement events, the count rose by 3.6%, from 1,773 in 2024 to 1,836 in 2025. Class II is 100.0% of its events and 73.7% of all FDA events.

See the 16 events

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 3 Nov 2026.

Enforcement events

16 events, newest first.

FDA enforcement events of Abbott Gmbh & Co. KG
Initiated	Product (first record)	Type	Class	Records	Status
19 Jun 2020	Alinity ci series System Control Module (SCM); LN 3R70-01 Alinity ci series software versions, 3.1.1 and below	Device	Class II	1	Terminated
12 May 2020	Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics.	Device	Class II	1	Terminated
24 Apr 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.	Device	Class II	1	Ongoing
9 Mar 2020	ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.	Device	Class II	1	Terminated
24 Jan 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.	Device	Class II	1	Terminated
7 Nov 2019	ARCHITECT HAVAB-G Calibrator, REF 6L27-01	Device	Class II	1	Terminated
23 Oct 2019	Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I. Inc. Prince Edward Island Canada	Device	Class II	1	Terminated
16 Sep 2019	Alinity ci Level Sensor, Bulk Solution	Device	Class II	3	Ongoing
10 Jun 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…	Device	Class II	1	Terminated
21 May 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…	Device	Class II	1	Terminated
15 Apr 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…	Device	Class II	1	Terminated
5 Apr 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…	Device	Class II	1	Terminated
7 Mar 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…	Device	Class II	1	Terminated
26 Feb 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…	Device	Class II	2	Terminated
20 Dec 2018	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…	Device	Class II	1	Terminated
14 Dec 2017	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.	Device	Class II	1	Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

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Type and class

Abbott Gmbh & Co. KG: events for each product type
Type		Events
Device		16

Abbott Gmbh & Co. KG: events in each class
Class		Events
Class II		16

Share of the events of the firm in Class I: 0%
Share of all events on the register in Class I: 18%
Events with the status Ongoing: 2

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Abbott Gmbh & Co. KG, by the year that the recall started. The largest year is 2019, with 9 events.

Official channels

FDA enforcement reportsThe FDA search of the weekly enforcement reports.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA: report a problemThe FDA page that shows where a report about a product goes.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Cite this page

Recall Register. Abbott Gmbh & Co. KG: FDA recalls. https://recallregister.com/firm/abbott-gmbh-co-kg/. Source: openFDA enforcement reports. Data through 3 Nov 2026.

Sources

Source: openFDA enforcement reports
Licence: CC0 1.0
Export date: 3 Nov 2026
State of the firm address: N/A

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not rate one firm against another. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Abbott Gmbh & Co. KG have?: Class II: 16 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Abbott Gmbh & Co. KG?: FDA event 85914, which the firm started on 19 Jun 2020. The first product in the record is: Alinity ci series System Control Module (SCM); LN 3R70-01 Alinity ci series software versions, 3.1.1 and below
How many FDA recalls of Abbott Gmbh & Co. KG have the status Ongoing?: 2 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.