| Date Initiated by Firm | March 29, 2012 |
|---|
| Date Posted | May 14, 2012 |
|---|
| Recall Status1 |
Terminated 3 on September 05, 2017 |
| Recall Number | Z-1546-2012 |
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| Recall Event ID |
61500 |
| 510(K)Number | K941398 |
|---|
| Product Classification |
System, test, rheumatoid factor - Product Code DHR
|
| 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). |
|---|
| Code Information |
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. |
| FEI Number |
1421346
|
Recalling Firm/
Manufacturer |
Thera Test Laboratories, Inc.
1111 N Main St
Lombard
IL
60148-1360
|
| For Additional Information Contact |
630-627-6069 |
|---|
Manufacturer 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. |
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FDA Determined
Cause 2 | Nonconforming Material/Component |
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| 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) |
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| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
|
| 510(K) Database | 510(K)s with Product Code = DHR
|
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