Z-1546-2012

RF IgA Calibrator, a component of the EL-RF/3 Rheumatoid Factor Test Kit; an in vitro diagnostic; TheraTest...

Name: Z-1546-2012 RF IgA Calibrator, a component of the EL-RF/3 Rheumatoid Factor Test Kit; an in vitro diagnostic; TheraTest...
Creator: Thera Test Laboratories, Inc.
Published: 2012-03-29
License: https://open.fda.gov/license/

Theratest Laboratories, Inc. / initiated 2012-03-29 / Terminated / root cause: manufacturing process

FDA source

Thera Test Laboratories, Inc. began a recall of 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... on 2012-03-29. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1546-2012
Status: Terminated
Initiated: 2012-03-29
Posted: 2012-05-14
Terminated: 2017-09-05
Recalling firm: Theratest Laboratories, Inc.
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).
Product code: DHR System, Test, Rheumatoid Factor
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 207 kits
Distribution: Nationwide Distribution (US)
Product codes and 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.

Product code DHR

K941398Class IIEl-Rf/3 (Igm-Igg-Iga) KitTheratest Laboratories, Inc. / cleared 1995-07-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)