Reported Jun 14, 2023 · Ongoing
Alinity i Anti-TPO Reagent Kit, List Number 09P3521
Abbott Ireland Limited
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Ireland Limited · Finisklin Business & Technology Park · Sligo · N/A
Is this the product you have?
- Alinity i Anti-TPO Reagent Kit, List Number 09P3521
- Lot codes and dates
- UDI Number(01)00380740153892(17)240720(10)46009FN00
- List Number09P3521
- Lot Number46009FN00
- Expiration Date07/20/2024
- Amount recalled
- 110 kits
Where it was sold
Why it was recalled
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).
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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