Alinity i TSH Reagent Kit recall
Alinity i TSH Reagent Kit, List Number 07P4830
Why was Alinity i TSH 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)00380740131159 (17)190710(10)90061UI00 / 90061UI00 (01)00380740131159 (17) 190827(10) 91526UI00 / 91526UI00 (01)00380740131159 (17)190924(10)92291UI00 / 92291UI00
- Product
- Alinity i TSH Reagent Kit, List Number 07P4830
- Recalling firm
- Abbott Ireland Diagnostics Division
- Quantity
- 678 units
- Distribution
- AR, FL, GA, MD, OK, VA
- Recall date
- January 2, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)