Recall Z-1031-03 ยท DHR System, Test, Rheumatoid Factor
Zeus Scientific Inc
Rheumatoid Factor ELISA Test Kit. Labeled under the following names: Sigma Diagnostics, Inc, Saint Louis, MO and Zeus Scientific, Inc Branchburg, NJ.
| Date | Jul 19, 2003 (initiated Nov 9, 2001) |
| Status | Terminated |
| Reason | Calibrator C not meeting its optical density specification. |
| Root cause | Other |
| Action | Customers were notified of the recall via DHL on 11/9/2001. Customers were instructed to return or destroy product. |
| Quantity | 505 |
| Distribution | The Sigma product was shipped to Sigma directly. The Zeus product was shipped to customers nationwide via DHL. Zeus customers consists of hospitals, and clinical laboratories. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961277 | RF IGM ELISA TEST SYSTEM Zeus Scientific, Inc., May 8, 1996 |