FDAClass IIIApril 25, 2018

Cocaine Metabolite MICRO-PLATE EIA recall

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

Why was Cocaine Metabolite MICRO-PLATE EIA recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000
Recalling firm
OraSure Technologies, Inc.
Quantity
10
Distribution
Distributed to 2 consignees in KS.
Recall date
April 25, 2018
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls