Alinity i Progesterone Reagent Kit recall
Alinity i Progesterone Reagent Kit, List Number 08P3620
Why was Alinity i Progesterone Reagent Kit 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/Lot Numbers (01)00380740121877 (17)190503(10) 91254UI00 / 91254UI00 (01)00380740121877 (17)190618(10)92360UI00 / 92360UI00
- Product
- Alinity i Progesterone Reagent Kit, List Number 08P3620
- Recalling firm
- Abbott Ireland Diagnostics Division
- Quantity
- 157 units
- Distribution
- AR, FL, GA, MD, OK, VA
- Recall date
- January 2, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)