RF IgA Calibrator, a component of the EL-RF/3 Rheumatoid Factor Test Kit; an in vitro diagnostic; TheraTest Laboratories
FDA device recall Z-1546-2012 · posted 2012-05-14 · Terminated
Recall details
- Recalling firm
- Thera Test Laboratories, Inc.
- 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.
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- DHR
- Quantity affected
- 207 kits
- Distribution
- Nationwide Distribution (US)
- Date initiated
- 2012-03-29
- Date posted
- 2012-05-14
- Date terminated
- 2017-09-05
- Location
- Lombard, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EL-RF/3 (IGM-IGG-IGA) KIT (K941398) | Theratest Laboratories, Inc. | 1995-07-28 |