Device product
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.
Z-0722-2017
Product summary
- Event
- Event 75681
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4 kits
- Official record key
device-enforcement:Z-0722-2017
Official wording
Reason: Shipping error. Cocaine metabolite Microplate distributed instead of Barbiturate Microplate due to incorrect selection of Microplate during manufacturing.
Code information: Lot # 6654085
Distribution pattern: Distributed to KS, and VA
Derived failure modes
-
Unknown
Shipping error. Cocaine metabolite Microplate distributed instead of Barbiturate Microplate due to incorrect selection of Microplate during manufacturing.