The Recall Desk

Manufacturer

Abbott Ireland Limited

1 recall in our database name Abbott Ireland Limited as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2023-06-14

Of the 1 recalls from Abbott Ireland Limited 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.

1–1 of 1

  • LowFDA (Devices)·Z-1696-2023·2023-06-14

    Abbott Alinity i Anti-TPO Reagent Kit Recalled for Fill Volume Error

    Abbott is recalling Alinity i Anti-TPO Reagent Kit (Lot 46009FN00) due to a manufacturing error resulting in marginally lower fill volume than specified in the Instructions for Use. Approximately 110 kits were distributed nationwide across 17 US states.

    Product
    Alinity i Anti-TPO Reagent Kit, List Number 09P3521
    Category
    Medical Device
    Distribution
    Distributed nationwide