OraSure Technologies, Inc. Recall 87340
Description: Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C.
OraSure Technologies, Inc. Recall 87340 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1183-2021 |
| Event ID | 87340 |
| Event Description | Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C. |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of KS, NJ, OH, VA. |
| Quantity | 16 units |
| Recall Reason | 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. |
| Device Classification | 20210317 |
| Device Code Info | Lot 6681090, Exp date 2021-03. UDI: 608337000191 |
| Center Classification Date | 20210305 |
| Recall Initiation Date | 20210205 |
| Recalling Firm | OraSure Technologies, Inc. |
| Initial Notification | Letter |
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