FDA Enforcement
Class III
Terminated
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.
Recall: Z-0722-2017
·
Reported December 14, 2016
Enforcement
- Recall Number
- Z-0722-2017
- Event ID
- 75681
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- OraSure Technologies, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Telephone
- Report Date
- December 14, 2016
- Initiation Date
- November 10, 2016
- Classification Date
- December 8, 2016
- Termination Date
- April 17, 2017
- Address
- 1745 Eaton Ave, N/A, Bethlehem, PA, 18018-1769, United States
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
Shipping error. Cocaine metabolite Microplate distributed instead of Barbiturate Microplate due to incorrect selection of Microplate during manufacturing.
Code Info
Lot # 6654085
Distribution
Distributed to KS, and VA
Quantity
4 kits