FDA Medical Device Recalls (openFDA)
Sentinel CH SpA: 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.
- Recall number
- Z-0164-2016
- Recalling firm
- Sentinel CH SpA
- 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.
- Status
- Terminated
- Initiated
- 2015-09-22
- Posted
- 2015-10-26
- Terminated
- 2016-03-30
- Reason
- Results for ammonia are below the linear range of the assay for samples that have been collected in sodium or lithium heparin tubes.
- Root cause
- Process control
- 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.
- Quantity
- 765 kits
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- Lot 50083Y600, expiration date 31 Jul 2016.
- 510(k) numbers
- ["K051114"]
- PMA numbers
- not on file
- Product code
- JIF
- Firm FEI
- 3000303338
- Firm city
- Milano
- Firm state
- not on file
- Firm country
- Italy
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28