Recall Z-2574-2018 ยท GNP Antiserum, Cf, Epstein-Barr Virus
Diamedix Corporation
Diamedix Is-EBV-EA-D IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-640
| Date | Jan 5, 2018 |
| Status | Terminated |
| Reason | Contains a gel-like contaminant that may affect product performance. |
| 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 do |
| Quantity | 147 |
| Distribution | AZ, CA, FL, IL, IN, KY, MA, MI, MN, MO, NH, NJ, NY, OH, OK, PA, RI, TN, TX, and WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981831 | IS EBV-EA-D IGG ELISA TEST SYSTEM Diamedix Corp., Feb 16, 1999 |