Reported Jan 2, 2019 · Terminated
Alinity i 25-OH Vitamin D Reagent Kit, List Number 08P4532
Abbott Ireland Diagnostics Division
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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 Diagnostics Division · Lisnamuck · Co. Longford · N/A
Is this the product you have?
Alinity i 25-OH Vitamin D Reagent KitList Number 08P4532
- Lot codes and dates
- UDI/Lot Numbers (01)00380740121952 (17)191011(10)92313UI00 / 92313UI00 (01)00380740121952 (17)190831(10)92484UI00 / 92484UI00
- Amount recalled
- 760 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument.
This product could cause temporary or reversible health problems — stop using it.
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