The Recall Desk

Manufacturer

Abbott Gmbh & Co. KG

19 recalls in our database name Abbott Gmbh & Co. KG as the manufacturing or recalling firm.

What the numbers show

Total
19
Critical
0
Severe
0
Most recent
2020-08-05

Of the 19 recalls from Abbott Gmbh & Co. KG we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–19 of 19

  • HighFDA (Devices)·Z-2701-2020·2020-08-05

    Abbott Alinity ci System Control Module Recalled for Quality Control Failures

    Abbott is recalling Alinity ci System Control Modules because quality control results were not properly evaluated for failures.

    Product
    Alinity ci series System Control Module (SCM); LN 3R70-01 Alinity ci series software versions, 3.1.1 and below
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2401-2020·2020-06-24

    Abbott Alinity C Processing Module Recalled for Incorrect Patient Results

    Abbott is recalling 421 Alinity C Processing Modules because they may generate incorrect results for specific chemistry assays.

    Product
    Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics.
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-2117-2020·2020-06-03

    Abbott Recalls Architect iGentamicin Reagent Kits Due to Assay Interaction

    Abbott is recalling 6,087 Architect iGentamicin Reagent Kits because they may interact with troponin assays, potentially impacting patient results.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1728-2020·2020-04-29

    Abbott Recalls Architect HAVAB G Reagent Kits Due to Antigen Concentration Error

    Abbott is recalling 7,347 Architect HAVAB G Reagent Kits because an erroneous concentration value was used during manufacture, resulting in a decreased amount of antigen.

    Product
    ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1580-2020·2020-04-01

    Abbott Alinity ci-series Software Recalled for Performance Issues

    Abbott is recalling Alinity ci-series software version 2.6.2 and earlier due to identified potential performance issues.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0575-2020·2019-12-04

    Abbott Recalls Alinity c Carbon Dioxide Reagent Kits Due to CO2 Absorption

    Abbott is recalling Alinity c Carbon Dioxide Reagent Kits because atmospheric carbon dioxide can be absorbed into the reagent, potentially causing incorrect test results.

    Product
    Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I. Inc. Prince Edward Island Canada
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0544-2020·2019-12-04

    Abbott Alinity i Accessory Kit Recalled for Potential Sensor Cracks

    Abbott is recalling Alinity i accessory kits because environmental stress may cause cracks in the bulk solution level sensor.

    Product
    Accessory kit, Alinity i containing Alinity ci Level Sensor, Bulk Solution
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0543-2020·2019-12-04

    Abbott Alinity ci Level Sensor Recalled for Potential Cracking

    Abbott is recalling Alinity ci Level Sensors, Bulk Solution, because environmental stress may cause cracks that affect reliability.

    Product
    Alinity ci Level Sensor, Bulk Solution
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0545-2020·2019-12-04

    Abbott Alinity ci Level Sensor Bulk Solution Recalled for Reliability Issues

    Abbott is recalling Alinity ci Level Sensor Bulk Solution kits due to potential cracks caused by environmental stress, which may affect reliability.

    Product
    Accessory kit, Alinity c containing Alinity ci Level Sensor, Bulk Solution
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2363-2019·2019-09-04

    Abbott Recalls Alinity ci Series System Control Modules Due to Software Error

    Abbott is recalling Alinity ci series System Control Modules because a software issue may cause incorrect test results after a system stop.

    Product
    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 c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2201-2019·2019-08-14

    Abbott Alinity ci-series System Control Modules Recalled for Software Defect

    Abbott is recalling 943 Alinity ci-series System Control Modules because software may fail to detect issues in specific electrolyte assays.

    Product
    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 sca
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1709-2019·2019-06-12

    Abbott Recalls Alinity c Cuvette Segments Due to Seating Defect

    Abbott is recalling Alinity c Cuvette Segments because individual cuvettes may seat lower than designed, potentially preventing the sample probe from making efficient contact with the cuvette bottom.

    Product
    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 auto
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1497-2019·2019-06-05

    Abbott Alinity i Processing Module Recalled for Potential Burn and Shock Hazards

    Abbott is recalling Alinity i Processing Modules due to potential loose cable connections that could cause reagent cooler failure, leading to burn or shock injuries.

    Product
    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 con
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1316-2019·2019-05-22

    Abbott Alinity ci-series System Control Module Software Recall

    Abbott is recalling Alinity ci-series System Control Module software version 2.5.1 due to potential performance issues.

    Product
    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
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-1196-2019·2019-04-24

    Abbott Alinity i Processing Module Recalled for Safety Interlock Defect

    Abbott is recalling Alinity i Processing Modules because a safety interlock may fail to deploy when a bulk solution bottle is removed.

    Product
    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 (C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1197-2019·2019-04-24

    Abbott Alinity c Processing Module Recalled for Safety Interlock Defect

    Abbott is recalling 559 Alinity c Processing Modules because a safety interlock may fail to deploy when a bulk solution bottle is removed.

    Product
    Abbott Alinity c Processing Module LN 03R67-01 - Product Usage: 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 photometric and potentiometric detection techno
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0789-2019·2019-02-06

    Abbott Recalls Alinity i Processing Modules Due to Gear Pump Assembly Issue

    Abbott is recalling Alinity i Processing Modules because a gear pump assembly issue causes foaming and dried residue in the wash buffer reservoir.

    Product
    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 auto
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1629-2018·2018-05-16

    Abbott ARCHITECT DHEA-S Reagent Recalled for False Infant Results

    Abbott is recalling ARCHITECT DHEA-S Reagent because it may produce falsely elevated results when used on samples from infants up to 60 days old.

    Product
    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.
    Category
    Medical Device
    Distribution
    31 states