Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended
FDA device recall Z-0164-2016 · posted 2015-10-26 · Terminated
Recall details
- Recalling firm
- Sentinel CH SpA
- 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.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JIF
- Quantity affected
- 765 kits
- Distribution
- Nationwide Distribution.
- Date initiated
- 2015-09-22
- Date posted
- 2015-10-26
- Date terminated
- 2016-03-30
- Location
- Milano, Italy
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY (K051114) | Sentinel Ch. Srl | 2005-11-25 |