Recall Z-1546-2012 ยท DHR System, Test, Rheumatoid Factor
Thera Test Laboratories, Inc.
RF IgA Calibrator, a component of the EL-RF/3 Rheumatoid Factor Test Kit; an in vitro diagnostic; TheraTest Laboratories, Lombard, IL 60148; component catalog #12833, kit catalog #303-305. The TheraTest EL-RF/3 is intended as an aid to the diagnosis of Rheumatoid Arthritis (RA).
| Date | May 14, 2012 (initiated Mar 29, 2012) |
| Status | Terminated |
| Reason | The RF IgA Calibrator component of the EL-RF/3 Rheumatoid Factor test system may be unstable, resulting in a drop in the RF IgA calibrator OD value which could invalidate an RF IgA test run. |
| Root cause | Nonconforming Material/Component |
| Action | TheraTest sent "Urgent Device Recall" letters dated March 28, 2012 to customers that received the affected kit, requesting them to return or destroy the remainder of the product. TheraTest issued a replacement kit to all customers that had unused product as well as any material they consumed which resulted in a failed run. Customers were also instructed to complete the enclosed confirmation form and fax the completed form back to TheraTest. Any questions were directed to TheraTest at 800-441-0771. |
| Quantity | 207 kits |
| Distribution | Nationwide Distribution (US) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K941398 | EL-RF/3 (IGM-IGG-IGA) KIT Theratest Laboratories, Inc., Jul 28, 1995 |