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).
FDA Recall Z-1546-2012 · Posted 2012-05-14
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Recalling FirmThera Test Laboratories, Inc.
Recall StatusTerminated
Product CodeDHR
Date Initiated2012-03-29
Date Terminated2017-09-05
Product Quantity207 kits
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.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide Distribution (US)
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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