FDA recall Z-2877-2020

Product

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

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.

Key facts

Status

Terminated

Initiation date

2020-07-13

Report date

2020-09-02

Termination date

2021-06-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bethlehem, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2877-2020