Z-2876-2020Class III

Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate Matrix Oral Fluid Coated...

Name: Z-2876-2020 Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate Matrix Oral Fluid Coated...
Creator: OraSure Technologies, Inc.
Published: 2020-07-13
License: https://open.fda.gov/license/

OraSure Technologies, Inc. / initiated 2020-07-13 / Terminated / root cause: manufacturing process

FDA source

OraSure Technologies, Inc. began a recall of Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate Matrix Oral Fluid Coated Micro-Plate-IVD Immunoassay for Benzodiazepines, Product... on 2020-07-13. FDA classified it as Class III and gives the reason as "Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or additionally same error on unit box". 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-2876-2020
Classification: Class III
Status: Terminated
Initiated: 2020-07-13
Posted: 2020-08-24
Terminated: 2021-06-08
Recalling firm: OraSure Technologies, Inc.
Product: Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate Matrix Oral Fluid Coated Micro-Plate-IVD Immunoassay for Benzodiazepines, Product Number: 1110IB
Product code: JXM Enzyme Immunoassay, Benzodiazepine
Reason for recall: Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or additionally same error on unit box
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: OraSure Technologies issued Advisory Letter dated July 17,2020 via email stating reason for letter and action to take: While this kit expired at the end of March, 2020; we wanted to take this opportunity to send an updated Specification Sheet with the lot number of the Oral Fluid Negative Calibrator corrected for your files. If you have any questions regarding this issue please contact ourTechnical Services Department at [email protected] and they can assist you .
Quantity in commerce: 39 kits
Distribution: Worldwide distribution - US Nationwide distribution including in the states of DC, FL, PA, MD, NM, NY, NV, PA and the country of France.
Product codes and lots: Lot Number: 6673115 Exp. Date:03/31/2020 UDI: 608337000238

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2876-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2876-2020	Class III	Terminated	Voluntary: Firm initiated	2020-09-02	2020-08-24
Z-2877-2020	Class III	Terminated	Voluntary: Firm initiated	2020-09-02	2020-08-24

Product code JXM

K013882Class IIOti Benzodiazepines Intercept Micro-Plate Eia Model #1110IOraSure Technologies, Inc. / cleared 2002-04-17

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)