Home / Recalls / OraSure Technologies, Inc. / Z-0722-2017

Z-0722-2017 Class III Terminated

Recalled by OraSure Technologies, Inc. — Bethlehem, PA

Recall Details

Product Type
Devices
Report Date
December 14, 2016
Initiation Date
November 10, 2016
Termination Date
April 17, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
4 kits

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.

Reason for Recall

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

Distribution Pattern

Distributed to KS, and VA

Code Information

Lot # 6654085

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