Z-2877-2020 Class III Terminated
FDA device recall Z-2877-2020 was initiated by OraSure Technologies, Inc. on July 13, 2020 and is designated Class III. 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 The recall status is terminated (terminated June 8, 2021). Affected quantity: 13 kits.
Recall Details
- Product Type
- Devices
- Report Date
- September 2, 2020
- Initiation Date
- July 13, 2020
- Termination Date
- June 8, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13 kits
Product Description
Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coated Micro-Plate. IVD Immunoassay for Benzodiazepines, Product Number: 1110IT
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
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.
Code Information
Lot Number: 6673116 Exp. Date:03/31/2020