Z-1183-2021Class III

Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral...

Name: Z-1183-2021 Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral...
Creator: OraSure Technologies, Inc.
Published: 2021-02-05
License: https://open.fda.gov/license/

OraSure Technologies, Inc. / initiated 2021-02-05 / Terminated / root cause: packaging

FDA source

OraSure Technologies, Inc. began a recall of Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C on 2021-02-05. FDA classified it as Class III and gives the reason as "Incorrect lot of Substrate Reagent (TMB) may be included in the kit. The original kit box labeling and the specification sheet listed the Substrate Reagent (TMB) lot 6676239, but contained Substrate Reagent (TMB) lot...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1183-2021
Classification: Class III
Status: Terminated
Initiated: 2021-02-05
Posted: 2021-03-05
Terminated: 2023-03-30
Recalling firm: OraSure Technologies, Inc.
Product: Methamphetamine Intercept Microplate kit EIA - IVD qualitative determination of methamphetamine in oral fluid, PN 11041C.
Product code: LAF Gas Chromatography, Methamphetamine
Reason for recall: Incorrect lot of Substrate Reagent (TMB) may be included in the kit. The original kit box labeling and the specification sheet listed the Substrate Reagent (TMB) lot 6676239, but contained Substrate Reagent (TMB) lot 6679623, should not affect performance.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Orasure issued Advisory Letters issued on 2/05/21 via Certified Mail receipt. Letter states reason for recall, health risk and action to take: OraSure Technologies, Inc. has generated a new Specification Sheet for the Methamphetamine Kit with the alternate Substrate Reagent Lot 6679623 included with this advisory letter. Retain testing done using the alternate Substrate Reagent revealed no impact to the kit's performance. If you have any questions regarding this issue please contact out Technical Services Department at technicalserviceQcorasure.coin and they can assist you
Quantity in commerce: 16 units
Distribution: US Nationwide distribution in the states of KS, NJ, OH, VA.
Product codes and lots: Lot 6681090, Exp date 2021-03. UDI: 608337000191

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1183-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1183-2021	Class III	Terminated	Voluntary: Firm initiated	2021-03-17	2021-03-05

Product code LAF

K993208Class IIStc Methamphetamine Intercept Micro-Plate Eia, Model 1104IOraSure Technologies, Inc. / cleared 2000-04-03

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)