Home / Recalls / OraSure Technologies, Inc. / Z-1419-2018

Z-1419-2018 Class III Terminated

Recalled by OraSure Technologies, Inc. — Bethlehem, PA

Recall Details

Product Type
Devices
Report Date
April 25, 2018
Initiation Date
December 20, 2017
Termination Date
April 2, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10

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.

Distribution Pattern

Distributed to 2 consignees in KS.

Code Information

Lot Number: 0006661251, Expiration date: 02/28/2018

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