Recall Z-2877-2020
OraSure Technologies, Inc. · initiated July 13, 2020
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coated Micro-Plate. IVD Immunoassay for Benzodiazepines, Product Number: 1110IT
Codes / lots: Lot Number: 6673116 Exp. Date:03/31/2020
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
FDA-determined 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 .
Details
- Recall number
- Z-2877-2020
- Initiated
- July 13, 2020
- Terminated
- June 8, 2021
- Product code
- JXM – Enzyme Immunoassay, Benzodiazepine
- Quantity
- 13 kits
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of DC, FL, PA, MD, NM, NY, NV, PA and the country of France.
- Recalling firm
- OraSure Technologies, Inc., Bethlehem, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2876-2020 Class III | Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate Matrix Oral…Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit… | 07/13/2020Terminated |