Device recall
Z-0529-2019: Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline Phosphatase…
FDA device recall · Class III · Helena Laboratories, Inc.
Key facts
| Recall number (Z-number) | Z-0529-2019 |
|---|---|
| Recall event | 81303 |
| Product | Gel Alkaline Phosphatase Isoenzyme Control Kit: Gel Alkaline Phosphatase Isoenzyme Control Cat. No. 5104 1 x 2.0 mL FOR IN-VITRO DIAGNOSTIC USE Gel Alkaline Phosphatase Isoenzyme Control 20mL 001831 Alkaline Phosphatase Isoenzyme Control is to be used as a qualitative and/or quantitative control to… |
| Product code | JJX |
| Recalling firm | Helena Laboratories, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jan 15, 2021 |
| 510(k) numbers | K895528 |
| 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