Device recall
Z-0812-2020: Microbiologics QC Sets and Panels, Gram-Positive Blood Culture Control Panel…
FDA device recall · Class II · Microbiologics Inc
Key facts
| Recall number (Z-number) | Z-0812-2020 |
|---|---|
| Recall event | 84524 |
| Product | Microbiologics QC Sets and Panels, Gram-Positive Blood Culture Control Panel (Inactivated Pellet), Catalog # 8180 Used in test systems to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. |
| Product code | OHQ |
| Recalling firm | Microbiologics Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 11, 2020 |
| FEI number | 2150138 |
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