Device product
Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000
Z-1419-2018
Product summary
- Event
- Event 79534
- Status
- Terminated
- Classification
- Class III
- Quantity
- 10
- Official record key
device-enforcement:Z-1419-2018
Official wording
Reason: The controls and calibrators contained within the cocaine test kit may cause false positive results with the negative control.
Code information: Lot Number: 0006661251, Expiration date: 02/28/2018
Distribution pattern: Distributed to 2 consignees in KS.
Derived failure modes
-
Unknown
The controls and calibrators contained within the cocaine test kit may cause false positive results with the negative control.