CLASS III Device recall · Reported 25 Apr 2018 · FDA Enforcement Report

Cocaine Metabolite Micro-plate EIA recalled by OraSure Technologies

OraSure Technologies is recalling Cocaine Metabolite Micro-plate EIA, distributed in Kansas. The recall was initiated on 20 Dec 2017 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot Number: 0006661251, Expiration date: 02/28/2018
Quantity recalled10

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-1419-2018
FDA event ID
79534
Recalling firm
OraSure Technologies, Bethlehem, PA
Classification
Class III
Status
Terminated
Recall initiated
20 Dec 2017
FDA classified
18 Apr 2018
Reported
25 Apr 2018
Type
Voluntary: Firm initiated
Customers notified by
Telephone
Reason category
Other Reasons

Timeline

20 Dec 2017Recall initiated by company
18 Apr 2018Classified by FDA+119 days
25 Apr 2018Published in enforcement report+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

Distributed to 2 consignees in KS.

Kansas

Questions about this recall

Is Cocaine Metabolite Micro-plate EIA recalled?

Yes. OraSure Technologies recalled Cocaine Metabolite Micro-plate EIA on 20 Dec 2017. The recall is Class III and its status is Terminated. Recall number Z-1419-2018.

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

Distributed to 2 consignees in KS.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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