Reported Mar 17, 2021 · Terminated
Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN…
OraSure Technologies, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: OraSure Technologies, Inc. · 220 E 1st St · Bethlehem, PA · 18015-1360
Is this the product you have?
- Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C.
- Lot codes and dates
Lot 6681090Exp date 2021-03
- UDI608337000191
- Amount recalled
- 16 units
Where it was sold
Why it was recalled
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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