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.
FDA Recall Z-0164-2016 · Posted 2015-10-26
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Recalling FirmSentinel CH SpA
Recall StatusTerminated
Product CodeJIF
Date Initiated2015-09-22
Date Terminated2016-03-30
Product Quantity765 kits
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.
Firm Action
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.
Root Cause
Process control
Distribution Pattern
Nationwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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