Device recall
Z-0286-2012: ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. 8001…
FDA device recall · Class II · Immunetech Inc
Key facts
| Recall number (Z-number) | Z-0286-2012 |
|---|---|
| Recall event | 60355 |
| Product | ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. 8001; Individually Packaged Kit, Product is manufactured distributed by ImmuneTech, Inc., Foster City, CA; but the non-sterile alcohol prep pads are manufactured by H & P Industries, Inc., Triad Group, Hartland, WI The MyAIIergyTest… |
| Product code | JKA |
| Recalling firm | Immunetech Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 14, 2012 |
| 510(k) numbers | K021698, K061979 |
| FEI number | 3004091547 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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