Z-2573-2018Class III

Diamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-540

Name: Z-2573-2018 Diamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-540
Creator: Diamedix Corporation
Published: 2018-01-05
License: https://open.fda.gov/license/

Diamedix Corp. / initiated 2018-01-05 / Terminated

FDA source

Diamedix Corporation began a recall of Diamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-540 on 2018-01-05. FDA classified it as Class III and gives the reason as "Contains a gel-like contaminant that may affect product performance". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2573-2018
Classification: Class III
Status: Terminated
Initiated: 2018-01-05
Posted: 2018-07-28
Terminated: 2019-11-05
Recalling firm: Diamedix Corp.
Product: Diamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-540
Product code: LJY Enzyme Linked Immunoabsorbent Assay, Mumps Virus
Reason for recall: Contains a gel-like contaminant that may affect product performance.
FDA root cause: Under Investigation by firm
Action: Diamedix sent a letter dated January 5th, 2018 was sent to all their customer with the following: Products contains a gel-like contaminant that may affect product performance.An inspection of the product in the Diamedix inventory confirmed this observation. Although, no failed runs have been directly attributed this issue, we feel that the best course of action is to replace the affected diluent. If you are using the reagent lot specified above, please discontinue use immediately. In order to process your replacement, please complete the attached Certificate of Destruction and return this document to Diamedix Customer Service via email: [email protected] or fax to (305) 418- 2321. If you have further questions or concerns you may contact our Technical Service Department at (305) 324-2307 or (800) 433-0945. Please be assured that Diamedix Corporation is working diligently to resolve the issues with this product. We apologize for any inconvenience that this may have caused and we thank you for your continued patience and support. Sincerely, Tracy Chadwrick Director, QA/QC
Quantity in commerce: 505
Distribution: AZ, CA, FL, IL, IN, KY, MA, MI, MN, MO, NH, NJ, NY, OH, OK, PA, RI, TN, TX, and WI
Product codes and lots: Lot S0406 Exp. 05/31/2018

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2573-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2573-2018	Class III	Terminated	Voluntary: Firm initiated	2018-08-08	2018-07-28
Z-2574-2018	Class III	Terminated	Voluntary: Firm initiated	2018-08-08	2018-07-28

Product code LJY

K991274Class IMumps Igg Elisa Test SystemColumbia Bioscience, Inc. / cleared 1999-09-03

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)