Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C.
Reported: March 17, 2021 Initiated: February 5, 2021 #Z-1183-2021
Product Description
Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C.
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.
Details
- Recalling Firm
- OraSure Technologies, Inc.
- Units Affected
- 16 units
- Distribution
- US Nationwide distribution in the states of KS, NJ, OH, VA.
- Location
- Bethlehem, PA
Frequently Asked Questions
What product was recalled? ▼
Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C.. Recalled by OraSure Technologies, Inc.. Units affected: 16 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 17, 2021. Severity: Low. Recall number: Z-1183-2021.
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