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Terminated

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

FDA Recall Z-2876-2020 · Posted None

Recalling FirmOraSure Technologies, Inc.
Recall StatusTerminated
Product CodeJXM
Date Initiated2020-07-13
Date Terminated2021-06-08
Product Quantity39 kits

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

Firm Action

OraSure Technologies issued Advisory Letter dated July 17,2020 via email stating reason for letter and action to take: While this kit expired at the end of March, 2020; we wanted to take this opportunity to send an updated Specification Sheet with the lot number of the Oral Fluid Negative Calibrator corrected for your files. If you have any questions regarding this issue please contact ourTechnical Services Department at [email protected] and they can assist you .

Root Cause

Under Investigation by firm

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K013882OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110IOraSure Technologies, Inc. · 2002-04-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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