Device recall
Z-0106-2019: "Free and Total Protein S ELISA Kit" Cat. No. 5292 For use in the quantitation…
FDA device recall · Class II · Helena Laboratories, Inc.
Key facts
| Recall number (Z-number) | Z-0106-2019 |
|---|---|
| Recall event | 81024 |
| Product | "Free and Total Protein S ELISA Kit" Cat. No. 5292 For use in the quantitation of free and total Protein antigen in citrated human plasma Contains: 96 Protein S: Ag Microwells, 3 x 0.5mL ELISA Reference Plasma, 1x12 mL Protein S Conjugate Solution, 1 x 60mL Sample Diluent, 1 x 13mL Substrate, 1 x… |
| Product code | GGP |
| Recalling firm | Helena Laboratories, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 14, 2020 |
| 510(k) numbers | K972482 |
| FEI number | 1618982 |
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