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Recall Observatory FDA recall evidence

Device product

Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000

Z-1419-2018

December 20, 2017

Class III

Product summary

Firm
OraSure Technologies, Inc.
Event
Event 79534
Status
Terminated
Classification
Class III
Quantity
10
Official record key
device-enforcement:Z-1419-2018

Official wording

Reason: The controls and calibrators contained within the cocaine test kit may cause false positive results with the negative control.

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

Distribution pattern: Distributed to 2 consignees in KS.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The controls and calibrators contained within the cocaine test kit may cause false positive results with the negative control.