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

Is my product affected?

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

• UPC 608337000191

Check against the official notice below — it lists the full affected range.

What happened

OraSure Technologies, Inc. is recalling 16 units of its Methamphetamine Intercept Microplate kit (model 11041C), a product used to detect methamphetamine in oral fluid samples. The kits were distributed nationwide in Kansas, New Jersey, Ohio, and Virginia. The recalled units have lot number 6681090 with an expiration date of March 2021.

The issue involves an incorrect lot of Substrate Reagent (TMB) included in the kits. The kit packaging and specification sheet indicated the reagent should be lot 6676239, but some kits contained lot 6679623 instead. According to the manufacturer, this discrepancy should not affect the product's performance. The source does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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 6679623, should not affect performance.

Details from the source

Reason for recall: 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 6679623, should not affect performance. Distribution: US Nationwide distribution in the states of KS, NJ, OH, VA. Quantity: 16 units Lot/code info: Lot 6681090, Exp date 2021-03. UDI: 608337000191

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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