Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C.

Recall Insight

This FDA Devices action (record #Z-1183-2021) was formally reported on March 17, 2021, with the manufacturer initiating the action on February 5, 2021. It is classified under Low severity (Class III), with a current status of Terminated. OraSure Technologies, Inc. is listed as the recalling firm, operating out of Bethlehem, PA. Federal records indicate 16 units units are affected.

The documented reason for this recall is: Incorrect lot of Substrate Reagent (TMB) may be included in the kit. The original kit box labeling and the specification sheet listed the Substrate Reagent (TMB) lot 6676239, but contained Substrate Reagent (TMB) lot 6… Distribution data in the federal record shows the product reached: US Nationwide distribution in the states of KS, NJ, OH, VA.. 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 5 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.