Device recall
Z-0536-2021: 3PLUS1 Multilevel Plasma Calibrator Set, Order No. 75128 - Product Usage: The…
FDA device recall · Class II · Chromsystems Instruments & Chemicals GmbH
Key facts
| Recall number (Z-number) | Z-0536-2021 |
|---|---|
| Recall event | 86719 |
| Product | 3PLUS1 Multilevel Plasma Calibrator Set, Order No. 75128 - Product Usage: The kit is intended for amino acid metabolic screening, confirmation of a tentative diagnosis, and monitoring of treatment in individuals diagnosed with a metabolic disorder. |
| Product code | JIX |
| Recalling firm | Chromsystems Instruments & Chemicals GmbH |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 20, 2021 |
| FEI number | 3003951180 |
At a glance
- None 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