Device recall
Z-0971-2019: ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31 The Magnesium assay is used…
FDA device recall · Class II · Abbott Laboratories, Inc
Key facts
| Recall number (Z-number) | Z-0971-2019 |
|---|---|
| Recall event | 81929 |
| Product | ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31 The Magnesium assay is used for the quantitation of magnesium in human serum, plasma, or urine. |
| Product code | JGJ |
| Recalling firm | Abbott Laboratories, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 30, 2021 |
| 510(k) numbers | K981791 |
| FEI number | 1628664 |
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