Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coated Micro-Plate. IVD Immunoassay for Benzodiazepines, Product Number: 1110IT
This recall has been terminated (originally issued July 13, 2020).
- Company
- Orasure Technologies, Inc.
- Recall Initiated
- July 13, 2020
- Terminated
- June 8, 2021
- Recall Number
- Z-2877-2020
- Quantity
- 13 kits
- Firm Location
- Bethlehem, PA
- Official Source
- View on FDA website ↗
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
Worldwide distribution - US Nationwide distribution including in the states of DC, FL, PA, MD, NM, NY, NV, PA and the country of France.
Lot / Code Info
Lot Number: 6673116 Exp. Date:03/31/2020
Root Cause
Under Investigation by firm
Action Taken
OraSure Technologies issued Advisory Letter dated July 17,2020 via email stating reason for letter and action to take: While this kit expired at the end of March, 2020; we wanted to take this opportunity to send an updated Specification Sheet with the lot number of the Oral Fluid Negative Calibrator corrected for your files. If you have any questions regarding this issue please contact ourTechnical Services Department at technicalservice@orasure.com and they can assist you .