Medical device recalls

OraSure Technologies, Inc. recalls Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate) Product is intended for use by clinical labora…

Recall date
November 10, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0722-2017
FDA classification
Class III
Brand / firm
OraSure Technologies, Inc.
Sold / distributed
Distributed to KS, and VA

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.

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