FDAFDA · Food and drugs·Recall number Z-0668-2019
Alinity i Progesterone Reagent Kit, List Number 08P3620
Published January 2, 2019 · Recall initiated: November 21, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Abbott Ireland Diagnostics Division
- Distributor
- AR, FL, GA, MD, OK, VA
- Lot
- UDI/Lot Numbers (01)00380740121877 (17)190503(10) 91254UI00 / 91254UI00 (01)00380740121877 (17)190618(10)92360UI00 / 92360UI00
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Ireland
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