Z-0164-2016Class II

Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN...

Name: Z-0164-2016 Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN...
Creator: Sentinel CH SpA
Published: 2015-09-22
License: https://open.fda.gov/license/

Sentinel CH SpA / initiated 2015-09-22 / Terminated / root cause: manufacturing process

FDA source

Sentinel CH SpA began a recall of Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended for the in vitro quantitative... on 2015-09-22. FDA classified it as Class II and gives the reason as "Results for ammonia are below the linear range of the assay for samples that have been collected in sodium or lithium heparin tubes". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0164-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-22
Posted: 2015-10-26
Terminated: 2016-03-30
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.
Product code: JIF Enzymatic Method, Ammonia
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 765 kits
Distribution: Nationwide Distribution.
Product codes and lots: Lot 50083Y600, expiration date 31 Jul 2016.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0164-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0164-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-04	2015-10-26

Product code JIF

K051114Class ISentinel Ammonia Ultra Diagnostic AssaySentinel Ch. Srl / cleared 2005-11-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)