Abbott Gmbh & Co. KG

FDA recalling firm · 16 enforcement events · 19 product records · 2017–2020 · N/A

Abbott Gmbh & Co. KG has 16 FDA enforcement events on this register (19 product records) between 2017 and 2020: 16 device; the busiest year was 2019 with 9.

0% of its events are Class I; the most common class is Class II (16). 2 events are listed as ongoing; the recalling firm's address is in N/A.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

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

By type and class

Device16

Class II16

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Abbott Gmbh & Co. KG by year initiated.

Questions and answers

How many FDA recalls has Abbott Gmbh & Co. KG had?

16 enforcement events (19 product records) on this register, 2017–2020: 16 device.

Are any Abbott Gmbh & Co. KG recalls ongoing?

2 events are listed as ongoing in the current openFDA export.

What class are Abbott Gmbh & Co. KG recalls?

16 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.