OraSure Technologies, Inc. recalls Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000
- Recall date
- December 20, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1419-2018
- FDA classification
- Class III
- Brand / firm
- OraSure Technologies, Inc.
- Sold / distributed
- Distributed to 2 consignees in KS.
Why it was recalled
The controls and calibrators contained within the cocaine test kit may cause false positive results with the negative control.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000
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