OraSure Technologies, Inc. recalls Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate Matrix Oral Fluid Coated Micro-Plate-IVD I…

Recall date

July 13, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2876-2020

FDA classification

Class III

Brand / firm

OraSure Technologies, Inc.

Sold / distributed

Worldwide distribution - US Nationwide distribution including in the states of DC, FL, PA, MD, NM, NY, NV, PA and the country of France.

Why it was recalled

Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or additionally same error on unit box

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate Matrix Oral Fluid Coated Micro-Plate-IVD Immunoassay for Benzodiazepines, Product Number: 1110IB