Medical DeviceAug 5, 2020
Abbott Gmbh & Co. KG Alinity ci series System Control Module (SCM) recall — FDA Z-2701-2020
Quality Control results were not properly evaluated for QC failures.
Class IIFDA: TerminatedAbbott Gmbh & Co. KG
Recall history in this database
Classification mix: Class II: 5.
Medical DeviceJun 24, 2020
Abbott Gmbh & Co. KG Alinity C, Processing Module recall — FDA Z-2401-2020
There is a potential to generate incorrect patient results for the following assays: Alkaline Phosphatase, Amylase, Creatine Kinase, and Gamma Glutamyl Transferase.
Class IIFDA: TerminatedAbbott Gmbh & Co. KG
Medical DeviceJun 3, 2020
Abbott Gmbh & Co. KG ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements recall — FDA Z-2117-2020
Abbott identified that samples tested for ARCHITECT STAT High Sensitive Troponin I and STAT High Sensitivity Troponin I assays (LN 3P25 and LN 2R98) may show interaction when processed…
Class IIFDA: OngoingAbbott Gmbh & Co. KG
Medical DeviceApr 29, 2020
Abbott Gmbh & Co. KG ARCHITECT HAVAB G Reagent Kit recall — FDA Z-1728-2020
An erroneous concentration value for hepatitis A virus was utilized during manufacture, leading to a decreased amount of antigen used for the impacted lots.
Class IIFDA: TerminatedAbbott Gmbh & Co. KG
Medical DeviceApr 1, 2020
Abbott Gmbh & Co. KG LN 3R70-01; software version 2.6.2 and earlier. The software is used recall — FDA Z-1580-2020
Abbott has identified potential performance issues for the Alinity ci -series Software version 2.6.2 and earlier.
Class IIFDA: TerminatedAbbott Gmbh & Co. KG
Understanding this recall history
This page summarizes recall records in which the official source identifies Abbott Gmbh & Co. KG as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.