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 Insight

This FDA Devices action (record #Z-0164-2016) was formally reported on November 4, 2015, with the manufacturer initiating the action on September 22, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Sentinel CH SpA is listed as the recalling firm, operating out of Milano, N/A. Federal records indicate 765 kits units are affected.

The documented reason for this recall is: Results for ammonia are below the linear range of the assay for samples that have been collected in sodium or lithium heparin tubes. Distribution data in the federal record shows the product reached: Nationwide Distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 11 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.