Medical device recalls

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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