Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate Matrix Oral Fluid Coated Micro-Plate-IVD Immunoassay for Benzodiazepines, Product Number: 1110IB
Check against the official notice below — it lists the full affected range.
OraSure Technologies is recalling 39 kits of its Interept Benzodiazepine Micro-Plate EIA immunoassay product due to an incorrect lot number listed for the Standard Oral Fluid Negative Calibrator on the specification sheet included in the kit and on the unit box. The affected product is Lot Number 6673115 with an expiration date of March 31, 2020, and was distributed worldwide, including throughout the United States and France.
The recall record does not specify a remedy or instructions for what consumers should do regarding this product.
Written by software from the official notice below. Not reviewed by a lawyer.
Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or additionally same error on unit box
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. Quantity: 39 kits Lot/code info: Lot Number: 6673115 Exp. Date:03/31/2020 UDI: 608337000238
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.