Abbott Laboratories

10 FDA enforcement actions

10 Total Recalls

0 Class I

10 Class II

0 Class III

Firm Details

Product Types: device, food
States: TX, CA, IL, OH

All Recalls

Class II: Risk 11/13/2025 device

Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance issues found in the Alinity ci-series System software versions 3.6.1. and lower that could lead to erroneous results for multiple analytes. The issue was identified by Abbott during the internal testing of complaint investigations.
Class II: Risk 09/18/2025 device

Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect results.
Class II: Risk 03/18/2025 device

When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.
Class II: Risk 03/18/2025 device

When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.
Class II: Risk 03/18/2025 device

When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.
Class II: Risk 03/18/2025 device

When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.
Class II: Risk 03/18/2025 device

When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.
Class II: Risk 06/14/2024 device

1)If Complete Blood Count with differential and reticulocyte(CBC+Diff+Retic) sample is run, then immediately following on same rack CBC+Diff sample is run, then falsely low red blood cell count may occur, generating falsely high Mean Cell Hemoglobin(MCH)/MCHC and falsely low hematocrit results. 2)Cell events may be incorrectly counted as basophil(BASO), resulting in increased BASO and %BASO counts
Class II: Risk 10/31/2023 food

Marketed towards preterm infants without approval as a new drug or licensed biologic, as well as unsafe food additive
Class II: Risk 03/28/2023 food

Potential of foreign material (hard plastic) within product

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.