Recall Z-2877-2020 ยท JXM Enzyme Immunoassay, Benzodiazepine
OraSure Technologies, Inc.
Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coated Micro-Plate. IVD Immunoassay for Benzodiazepines, Product Number: 1110IT
| Date | Jul 13, 2020 |
| Status | Terminated |
| Reason | Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or additionally same error on unit box |
| Root cause | Under Investigation by firm |
| Action | 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 . |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013882 | OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110I OraSure Technologies, Inc., Apr 17, 2002 |