Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA… — Class III medical device recall Z-2876-2020
Terminated recall by OraSure Technologies, Inc., reported 2020-09-02, distributed nationwide. Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or
| Recall number | Z-2876-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | OraSure Technologies, Inc., Bethlehem, PA, United States |
| Recall initiated | 2020-07-13 |
| Classified | 2020-08-24 |
| Reported by FDA | 2020-09-02 |
| Terminated | 2021-06-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | FR |
| Quantity | 39 kits |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00608337000238 |
| Lot numbers | 6673115 |
| Expiration dates | 2020-03-31 |
Product
Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate Matrix Oral Fluid Coated Micro-Plate-IVD Immunoassay for Benzodiazepines, Product Number: 1110IB
Reason for recall
Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or additionally same error on unit box
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-2876-2020. 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.