Device recall
Z-1546-2012: RF IgA Calibrator, a component of the EL-RF/3 Rheumatoid Factor Test Kit; an in…
FDA device recall · Class II · Thera Test Laboratories, Inc.
Key facts
| Recall number (Z-number) | Z-1546-2012 |
|---|---|
| Recall event | 61500 |
| 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 |
| Recalling firm | Thera Test Laboratories, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 5, 2017 |
| 510(k) numbers | K941398 |
| FEI number | 1421346 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database