OraSure Technologies, Inc.: Medical Device Recall in 2020 - (Recall #: Z-2876-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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

Product Classification:

Class III

Date Initiated: July 13, 2020

Date Posted: September 2, 2020

Recall Number: Z-2876-2020

Event ID: 86122

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

Status: Terminated

Product Quantity: 39 kits

Code Information:

Lot Number: 6673115 Exp. Date:03/31/2020 UDI: 608337000238

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.

Voluntary or Mandated:

Voluntary: Firm initiated