AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma

Recall Insight

This FDA Devices action (record #Z-2965-2020) was formally reported on September 23, 2020, with the manufacturer initiating the action on July 30, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. RANDOX LABORATORIES, LTD. is listed as the recalling firm, operating out of Crumlin Colorado Antrim, N/A. Federal records indicate 143 kits in total units are affected.

The documented reason for this recall is: Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140¿mol/l being observed on patient samples. Distribution data in the federal record shows the product reached: US Distribution to states of: VA, UT, WV and country of : Canada. 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 6 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.