Device recall
Z-2409-2018: Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003 Product…
FDA device recall · Class II · Immuno-Mycologics, Inc
Key facts
| Recall number (Z-number) | Z-2409-2018 |
|---|---|
| Recall event | 80284 |
| Product | Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Model # CR2003 Product Usage: The CrAg Lateral Flow Assay is an immunochromatographic test system for the qualitative or semi-quantitative detection of the capsular polysaccharide antigens of Cryptococcus species complex (Cryptococcus neoformans… |
| Product code | GMD |
| Recalling firm | Immuno-Mycologics, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 21, 2020 |
| 510(k) numbers | K112422 |
| FEI number | 1627497 |
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