Recall Z-0164-2016
Sentinel CH SpA · initiated September 22, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended for the in vitro quantitative determination of Ammonia (NH3) in human plasma.
Codes / lots: Lot 50083Y600, expiration date 31 Jul 2016.
Reason for recall
Results for ammonia are below the linear range of the assay for samples that have been collected in sodium or lithium heparin tubes.
FDA-determined cause: Process control
Action taken
Sentinel Urgent Field Safety Notice issued on 9/22/15 by Abbott to customers, including their US customers. Actions to be Taken 1. Immediately discontinue use of lot 50083Y600 and destroy any remaining inventory. 2. Order a replacement Ammonia Ultra reagent lot. 3. Follow your individual laboratory protocol regarding reviewing previously reported patient results. 4. Please retain this communication for future reference. If you have forwarded any MULTIGENT Ammonia Ultra reagent lot 50083Y600 to another laboratory, please provide a copy of this letter to them. Contacts If you or any of the health care providers you serve have any questions regarding this information, U.S. Customers should contact Customer Service at 1-877-4 ABBOTT.
Details
- Recall number
- Z-0164-2016
- Initiated
- September 22, 2015
- Posted by FDA
- October 26, 2015
- Terminated
- March 30, 2016
- Product code
- JIF – Enzymatic Method, Ammonia
- Quantity
- 765 kits
- Distribution
- Nationwide Distribution.
- Recalling firm
- Sentinel CH SpA, Milano