Methamphetamine Intercept Microplate kit EIA — Class III medical device recall Z-1183-2021
Terminated recall by OraSure Technologies, Inc., reported 2021-03-17, distributed nationwide. Incorrect lot of Substrate Reagent (TMB) may be included in the kit. The original kit box labeling and the spe
| Recall number | Z-1183-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | OraSure Technologies, Inc., Bethlehem, PA, United States |
| Recall initiated | 2021-02-05 |
| Classified | 2021-03-05 |
| Reported by FDA | 2021-03-17 |
| Terminated | 2023-03-30 |
| Distributed | Nationwide (US) |
| Quantity | 16 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00608337000191 |
| Lot numbers | 2021-03, 6681090 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1183-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.