Diamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-540
FDA Recall Z-2573-2018 · Posted None
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Recalling FirmDiamedix Corporation
Recall StatusTerminated
Product CodeLJY
Date Initiated2018-01-05
Date Terminated2019-11-05
Product Quantity505
Reason for Recall
Contains a gel-like contaminant that may affect product performance.
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
Root Cause
Under Investigation by firm
Distribution Pattern
AZ, CA, FL, IL, IN, KY, MA, MI, MN, MO, NH, NJ, NY, OH, OK, PA, RI, TN, TX, and WI
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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