Abbott Gmbh & Co. KG

Complete recall history across all FDA and CPSC categories — 19 total recalls

Abbott Gmbh & Co. KG appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (19)

FDA medical device enforcement actions by Abbott Gmbh & Co. KG

Date Product Reason Class
Jun 19, 2020 Alinity ci series System Control Module (SCM); LN 3R70-01 Alinity ci series ... Quality Control results were not properly evaluated for QC failures. Class II
May 12, 2020 Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics. There is a potential to generate incorrect patient results for the following ... Class II
Apr 24, 2020 ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained ... Abbott identified that samples tested for ARCHITECT STAT High Sensitive Tropo... Class II
Mar 9, 2020 ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25. An erroneous concentration value for hepatitis A virus was utilized during ma... Class II
Jan 24, 2020 LN 3R70-01; software version 2.6.2 and earlier. The software is used with th... Abbott has identified potential performance issues for the Alinity ci -series... Class II
Nov 7, 2019 ARCHITECT HAVAB-G Calibrator, REF 6L27-01 Abbott has identified that Calibrator lot 08219BE00 is potentially impacted b... Class II
Oct 23, 2019 Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnos... Abbott internal studies have determined that atmospheric Carbon Dioxide (CO2)... Class II
Sep 16, 2019 Accessory kit, Alinity c containing Alinity ci Level Sensor, Bulk Solution Potential reliability issue with the Alinity ci series Level Sensor, Bulk So... Class II
Sep 16, 2019 Alinity ci Level Sensor, Bulk Solution Potential reliability issue with the Alinity ci series Level Sensor, Bulk So... Class II
Sep 16, 2019 Accessory kit, Alinity i containing Alinity ci Level Sensor, Bulk Solution Potential reliability issue with the Alinity ci series Level Sensor, Bulk So... Class II
Jun 10, 2019 Alinity ci -series System Control¿Module, Part Number 03R70 01 Product Usa... Abbott has identified an issue with all on market versions (v2.6.0 and v2.6.1... Class II
May 21, 2019 The Alinity ci-series System Control Modules which are configured with Alinit... All versions of the Alinity ci-series software may not detect an issue on the... Class II
Apr 15, 2019 Alinity c Cuvette Segments, List Number 04S47-01 Product Usage: The Alinity... Individual cuvettes within the Alinity c Cuvette Segment may become seated lo... Class II
Apr 5, 2019 Alinity i Processing Module, 03R65 01, with the below components. a. TED (... Potential loose cable connections on the reagent cooler, which could result i... Class II
Mar 7, 2019 Abbott Alinity ci-series System Control Module software version 2.5.1; LN 3R7... Potential performance issues in the Alinity-ci software version 2.5.1 Class II
Feb 26, 2019 Abbott Alinity i Processing Module LN 03R65-01 - Product Usage: The Alinity i... The safety interlock covering the septum piercing probes within the bulk solu... Class II
Feb 26, 2019 Abbott Alinity c Processing Module LN 03R67-01 - Product Usage: The Alinity c... The safety interlock covering the septum piercing probes within the bulk solu... Class II
Dec 20, 2018 Alinity i Processing Module, (a) Part Number 03R65-01 (b) Part Number A-30... Abbott has identified an issue with the Alinity i Gear Pump Assembly (part nu... Class II
Dec 14, 2017 ARCHITECT DHEA-S Reagent Product Usage: It is a chemiluminescent micropar... Falsely elevated results may be obtained when using the ARCHITECT DHEA-S assa... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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