FDA Device recall Z-2876-2020
Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate Matrix Oral Fluid Coated Micro-Plate-IVD Immunoassay for Benzo…
- FDA Device
- Class III
- terminated
- Published 2020-09-02
On 2020-09-02 the FDA classified a Class III recall of Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate Matrix Oral Fluid Coated Micro-Plate-IVD Immunoassay for Benzo… by Orasure Technologies, citing incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or additionally same error on unit box.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2876-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2020-07-13 |
| Published | 2020-09-02 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Orasure Technologies |
| Distribution | US |
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
Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or additionally same error on unit box
Identifiers
| code_info | Lot Number: 6673115 Exp. Date:03/31/2020 UDI: 608337000238 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2876-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.