Z-0722-2017 Class III Terminated
FDA device recall Z-0722-2017 was initiated by OraSure Technologies, Inc. on November 10, 2016 and is designated Class III. Reason for recall: Shipping error. Cocaine metabolite Microplate distributed instead of Barbiturate Microplate due to incorrect selection of Microplate during manufacturing. The recall status is terminated (terminated April 17, 2017). Affected quantity: 4 kits.
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