Recall Z-2573-2018
Diamedix Corporation · initiated January 5, 2018
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
Diamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-540
Codes / lots: Lot S0406 Exp. 05/31/2018
Reason for recall
Contains a gel-like contaminant that may affect product performance.
FDA-determined cause: Under Investigation by firm
Action taken
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
Details
- Recall number
- Z-2573-2018
- Initiated
- January 5, 2018
- Terminated
- November 5, 2019
- Product code
- LJY – Enzyme Linked Immunoabsorbent Assay, Mumps Virus
- Quantity
- 505
- Distribution
- AZ, CA, FL, IL, IN, KY, MA, MI, MN, MO, NH, NJ, NY, OH, OK, PA, RI, TN, TX, and WI
- Recalling firm
- Diamedix Corporation, Miami Lakes, FL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2574-2018 Class III | Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog…Contains a gel-like contaminant that may affect product performance. | 01/05/2018Terminated |