Every recall we track for Abbott Gmbh & Co. KG — 19 in all — plus the complaints and injury reports the public filed about them.
Abbott recalls Alinity ci series System Control Module software versions 3.1.1 and below due to quality control failures. Affected units may have QC failures that could impact testing accuracy.
Abbott recalls Alinity C processing modules for potential incorrect patient results in alkaline phosphatase, amylase, creatine kinase, and gamma glutamyl transferase tests.
Abbott recalls ARCHITECT iGentamicin Reagent Kit (model 1P31-25) due to possible inaccurate test results when used with certain troponin tests. Affected lots: 04281BE00 (until May 2020), 08510BE00 (until Aug 2020), 11221BE00 (until Nov 2020).
Abbott recalls ARCHITECT HAVAB G Reagent Kit (List 6L27 25) due to potential decreased hepatitis A virus antigen. Affected lots may produce inaccurate test results. Consumers should contact Abbott for details.
Abbott recalls Alinity i devices with software version 2.6.2 and earlier due to potential performance issues. Affected users should contact Abbott for details.
Abbott recalls ARCHITECT HAVAB-G Calibrator lot 08219BE00 due to potential false non-reactive results in patient testing. Affected units may show incorrect results between 0.50-0.99 S/CO.
Abbott recalls Alinity c Carbon Dioxide Reagent Kits produced in Prince Edward Island, Canada, due to potential for incorrect test results from absorbed atmospheric CO2.
Abbott recalls Alinity c accessory kits with Level Sensor and Bulk Solution due to potential cracks from environmental stress. Affected units may need replacement.
Abbott recalls Alinity ci Level Sensor Bulk Solution due to potential cracks from environmental stress. Affected units have serial numbers listed in the recall notice.
Abbott recalls Alinity i accessory kits with Level Sensor and Bulk Solution due to potential cracks from environmental stress. Affected units include all serial numbers of List Number 03R66 03.
Abbott recalls Alinity ci series System Control Module (v2.6.0/v2.6.1) due to potential incorrect test results after system stops. Affected units may need software update to prevent errors.
Abbott recalls Alinity ci-series System Control Modules that may not detect sodium, potassium, and chloride levels in electrolyte tests. This could lead to inaccurate results for these critical blood tests.
Abbott recalls Alinity c Cuvette Segments (List 04S47-01) due to potential inadequate sample dispensing. Affected units may cause inaccurate test results. Contact Abbott for details.
Abbott recalls Alinity i Processing Module 03R65 01 with potential loose cable connections causing temperature errors and reagent cooler failure, risking burns and shocks.
Abbott recalls Alinity ci-series System Control Module software version 2.5.1 (LN 3R70-01) due to potential performance issues. Affected units include specific hardware components for Alinity i and Alinity c analyzers.
Abbott recalls Alinity i Processing Module LN 03R65-01 due to potential safety interlock failure when removing bulk solution bottles from the Alinity i series. This could lead to unsafe conditions during use.
Abbott recalls Alinity c Processing Module LN 03R67-01 due to potential safety interlock failure when removing bulk solution bottles, which could lead to improper operation.
Abbott recalls Alinity i Processing Modules with specific part numbers due to foaming and dried residue in the buffer reservoir, which may affect test accuracy. Affected units include serial numbers Ai01001-Ai01455, Ai01457, Ai01459.
Abbott recalls ARCHITECT DHEA-S reagent kits that may produce falsely elevated DHEA-S test results when used on infants up to 60 days old. Affected lots have specific expiration dates and unique identifiers.
