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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