Drug recall
Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coated…
FDA recall event 86122 · Class III · OraSure Technologies, Inc.
Key facts
| Event ID | 86122 |
|---|---|
| Recall numbers | Z-2876-2020, Z-2877-2020 |
| Recalling firm | OraSure Technologies, Inc. |
| Product type | Devices |
| Products | Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coated Micro-Plate. IVD Immunoassay for Benzodiazepines, Product Number: 1110IT, Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate Matrix Oral Fluid Coated Micro-Plate-IVD Immunoassay for Benzodiazepines, Product Number: 1110IB |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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 |
| Initiation date | Jul 13, 2020 |
| Report date | Sep 2, 2020 |
| Termination date | Jun 8, 2021 |
| City | Bethlehem |
| State | PA |
| Country | United States |
| FEI number | 3004142665 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: