OraSure Technologies, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0722-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate) Product is intended for use by clinical laboratories in the qualitative determination of barbiturates in oral fluids.

Product Classification:

Class III

Date Initiated: November 10, 2016

Date Posted: December 14, 2016

Recall Number: Z-0722-2017

Event ID: 75681

Reason for Recall:

Shipping error. Cocaine metabolite Microplate distributed instead of Barbiturate Microplate due to incorrect selection of Microplate during manufacturing.

Status: Terminated

Product Quantity: 4 kits

Code Information:

Lot # 6654085

Distribution Pattern:

Distributed to KS, and VA

Voluntary or Mandated:

Voluntary: Firm initiated