FDA-Device2016-12-14Class III

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.

OraSure Technologies, Inc.
Hazard

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

Sold states
Distributed to KS, and VA
Affected count
4 kits
Manufactured in
1745 Eaton Ave, N/A, Bethlehem, PA, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0722-2017

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