FDA-Device2020-09-02Class III
Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coated Micro-Plate. IVD Immunoassay for Benzodiazepines, Product Number: 1110IT
OraSure Technologies, Inc.
Hazard
Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or additionally same error on unit box
Sold states
Worldwide distribution - US Nationwide distribution including in the states of DC, FL, PA, MD, NM, NY, NV, PA and the country of France.
Affected count
13 kits
Manufactured in
220 E 1st St, N/A, Bethlehem, PA, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2877-2020Don't want to check this manually?
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