Recall Z-2877-2020— OraSure Technologies, Inc.

Name: FDA recall Z-2877-2020
Creator: U.S. Food and Drug Administration
Published: 2020-07-13

Class III · Terminated

Class III FDA medical device recall by OraSure Technologies, Inc., initiated 2020-07-13, terminated 2021-06-08. It names one FDA 510(k) clearance: K013882. 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: Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or additionally same error on unit box.

Recalling firm: OraSure Technologies, Inc.
Classification: Class III
Status: Terminated
Initiated: 2020-07-13
Terminated: 2021-06-08
Firm location: Bethlehem, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K013882 — OTI BENZODIAZEPINES INTERCEPT MICRO-PLATE EIA MODEL #1110IOraSure Technologies, Inc.·cleared 2002-04-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.