Device recall
Z-0732-2019: PREMIER Cryptococcal Antigen, Catalog Number 602096 Product Usage: The PREMIER…
FDA device recall · Class II · Meridian Bioscience Inc
Key facts
| Recall number (Z-number) | Z-0732-2019 |
|---|---|
| Recall event | 81787 |
| Product | PREMIER Cryptococcal Antigen, Catalog Number 602096 Product Usage: The PREMIER Cryptococcal Antigen enzyme immunoassay (EIA) is a screening or a semi-quantitative test system for the detection of capsular polysaccharide antigens of Cryptococcus neoformans in serum and cerebrosoinal fluid (CSF). |
| Product code | MDU |
| Recalling firm | Meridian Bioscience Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 30, 2020 |
| 510(k) numbers | K904393 |
| FEI number | 1524213 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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