Z-1419-2018Class III

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

Name: Z-1419-2018 Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000
Creator: OraSure Technologies, Inc.
Published: 2017-12-20
License: https://open.fda.gov/license/

OraSure Technologies, Inc. / initiated 2017-12-20 / Terminated / root cause: manufacturing process

FDA source

OraSure Technologies, Inc. began a recall of Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000 on 2017-12-20. FDA classified it as Class III and gives the reason as "The controls and calibrators contained within the cocaine test kit may cause false positive results with the negative control". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1419-2018
Classification: Class III
Status: Terminated
Initiated: 2017-12-20
Posted: 2018-04-18
Terminated: 2020-04-02
Recalling firm: OraSure Technologies, Inc.
Product: Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000
Product code: DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Reason for recall: The controls and calibrators contained within the cocaine test kit may cause false positive results with the negative control.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: The email to the firm's consignees states the controls will be replaced.
Quantity in commerce: 10
Distribution: Distributed to 2 consignees in KS.
Product codes and lots: Lot Number: 0006661251, Expiration date: 02/28/2018

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1419-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1419-2018	Class III	Terminated	Voluntary: Firm initiated	2018-04-25	2018-04-18

Product code DIO

K982061Class IIStc Cocaine Metabolite Micro-Plate Eia (Orasure Device)OraSure Technologies, Inc. / cleared 1998-08-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)