Recall Z-1907-2019 ยท DHR System, Test, Rheumatoid Factor
Phadia Ab
EliA RF IgM Well, REF 14-5600-01 Product Usage: Usage: EliA RF IgM is intended for the in vitro quantitative measurement of IgM class rheumatoid factor antibodies in human serum and plasma (Li-heparin and EDTA) to aid in the diagnosis of rheumatoid arthritis in conjunction with other laboratory and clinical findings. EliA RF IgM uses the EliA IgM method on the instrument Phadia 100, Phadia 250,
| Date | May 10, 2019 |
| Status | Terminated |
| Reason | Potential for reporting low assay results |
| Root cause | Nonconforming Material/Component |
| Action | On May 10, 2019, Corporate Thermo Fisher Scientific issued URGENT FIELD SAFETY NOTICES to customers by FedEx. Actions To Be Taken: Please review patient results obtained from lot 0085 and make note of the following: 1. If you have any of the above referenced material on hand, please discontinue use immediately and discard per your internal procedures. Notify all affected users in your facility to do the same. 2. All samples reported as positive (> 5 IU/ml) are positive, however the true concentration could be higher than reported. 3. The true concentration of a reported sample equal to 3. |
| Quantity | 30 kits |
| Distribution | US Nationwide n the states of NJ, NY, MI, WV, TX including PR |
| FDA record | Open on fda.gov |