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FDAJuly 13, 2020device

Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coated Micro-Plate. IVD Immunoassay for Benzodiazepines, Product Number: 1110IT

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

orasure technologiesorasure

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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