medical Class III Updated 2020-09-02

OraSure Technologies, Inc. recalls Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-

Recalled Product

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

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Number: 6673115 Exp. Date:03/31/2020 UDI: 608337000238
View official government recall

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