Recall Z-1546-2012
Thera Test Laboratories, Inc. · initiated March 29, 2012
Product
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).
Codes / lots: RF IgA Calibrator: component catalog number 12833, lot number 11118586, exp. 28 DEC 2012; EL-RF/3: kit catalog number 303-305, lot number 11118583, exp. 28 NOV 2012.
Reason for recall
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
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.
Details
- Recall number
- Z-1546-2012
- Initiated
- March 29, 2012
- Posted by FDA
- May 14, 2012
- Terminated
- September 5, 2017
- Product code
- DHR – System, Test, Rheumatoid Factor
- Quantity
- 207 kits
- Distribution
- Nationwide Distribution (US)
- Recalling firm
- Thera Test Laboratories, Inc., Lombard, IL