Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000
FDA Recall #Z-1419-2018 — Class III — December 20, 2017
Product Description
Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000
Reason for Recall
The controls and calibrators contained within the cocaine test kit may cause false positive results with the negative control.
Recalling Firm
OraSure Technologies, Inc. — Bethlehem, PA
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Devices
Product Quantity
10
Distribution
Distributed to 2 consignees in KS.
Code Information
Lot Number: 0006661251, Expiration date: 02/28/2018
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated