FDA Device

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

Hazard

Contains a gel-like contaminant that may affect product performance.

What You Should Do

Remedy

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: CustomerService@erbadiagnostics.com 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

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Products

Diamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-540
Brand
Diamedix Corporation
UPC
Lot S0406 Exp. 05/31/2018

Units Affected

505

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