Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000
This recall has been terminated (originally issued December 20, 2017).
- Company
- Orasure Technologies, Inc.
- Recall Initiated
- December 20, 2017
- Terminated
- April 2, 2020
- Recall Number
- Z-1419-2018
- Quantity
- 10
- Firm Location
- Bethlehem, PA
- Official Source
- View on FDA website ↗
Reason for Recall
The controls and calibrators contained within the cocaine test kit may cause false positive results with the negative control.
Distribution
Distributed to 2 consignees in KS.
Lot / Code Info
Lot Number: 0006661251, Expiration date: 02/28/2018
Root Cause
Under Investigation by firm
Action Taken
The email to the firm's consignees states the controls will be replaced.
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