Device product
Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate Matrix Oral Fluid Coated Micro-Plate-IVD Immunoassay for Benzodiazepines, Product Number: 1110IB
Z-2876-2020
Product summary
- Event
- Event 86122
- Status
- Terminated
- Classification
- Class III
- Quantity
- 39 kits
- Official record key
device-enforcement:Z-2876-2020
Official wording
Reason: Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or additionally same error on unit box
Code information: Lot Number: 6673115 Exp. Date:03/31/2020 UDI: 608337000238
Distribution pattern: Worldwide distribution - US Nationwide distribution including in the states of DC, FL, PA, MD, NM, NY, NV, PA and the country of France.
Derived failure modes
-
Unknown
Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or additionally same error on unit box