FDA Class III Recall: Alinity i Anti-TPO Reagent Kit, List Number 09P3521 by Abbott Ireland Limited

Key facts

What this classification means

A Class III recall is FDA’s least serious classification. FDA assigns Class III when use of, or exposure to, the recalled product is not likely to cause any adverse health consequences, but the product still violates FDA labeling or manufacturing regulations. Class III recalls are still tracked and reported to FDA, but typically receive lighter monitoring than Class I or II. FDA's Center for Devices and Radiological Health (for devices) or Center for Drug Evaluation and Research (for drugs) reviews the classification and can require additional corrective action if the initial response is judged insufficient. Because this record is filed as Class III, professionals and consumers handling an affected lot should treat FDA's own classification -- not this page's summary of it -- as the authoritative risk signal. A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case -- it reflects FDA’s assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field. A Class II recall is FDA’s middle classification. FDA assigns Class II when use of, or exposure to, the recalled product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. FDA still requires the recalling firm to notify affected accounts and submit status reports on the correction, though the monitoring intensity is lower than for a Class I recall.

What consumers should do

Facilities, clinicians, and consumers holding an affected unit or lot of Alinity i Anti-TPO Reagent Kit, List Number 09P3521 should stop using it for the purpose described in the recall notice and hold remaining stock pending instructions from Abbott Ireland Limited. FDA recall records typically direct the recalling firm to notify known accounts directly with a recall letter describing the specific corrective action -- replacement, field correction, refund, or return. Anyone who received the product through a distributor rather than directly from Abbott Ireland Limited should confirm with their supplier whether their specific lot or unit is on the affected list, since recall notices are lot- or unit-specific and not every unit of a product line is necessarily included. Questions about a specific unit's status should go to Abbott Ireland Limited directly or to the distributor that supplied it; Argus HQ is a public-record aggregator, not the recalling firm, and cannot confirm individual unit status.

Abbott Ireland Limited’s FDA history

Argus HQ has recorded 1 total FDA action tied to Abbott Ireland Limited: 0 warning letters, 1 recall, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What is the recall class for Abbott Ireland Limited's recall?

FDA classified this recall as Class III. A Class III recall is FDA’s least serious classification. FDA assigns Class III when use of, or exposure to, the recalled product is not likely to cause any adverse health consequences, but the product still violates FDA labeling or manufacturing regulations.

Why was Alinity i Anti-TPO Reagent Kit, List Number 09P3521 recalled?

FDA's recall record states the reason as: Due to a manufacturing fill volume error, Alinity i Anti-TPO Reagent contains a marginally lower fill volume than detailed in the Kit Contents section of the Instructions for Use (IFU).

Who should I contact about this recall?

Contact Abbott Ireland Limited directly, or the distributor/pharmacy that supplied the product, to confirm whether your specific lot or unit is affected. Argus HQ aggregates the public FDA recall record and is not the recalling firm.

Has Abbott Ireland Limited had other FDA recalls or enforcement actions?

This is the only FDA action Argus HQ has on file for Abbott Ireland Limited so far. Argus ingests new FDA enforcement records daily.

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