Device recall
Z-0770-04: Giardia/ Cryptosporidium Rapid In-vitro diagnostic Test kits. These are sold…
FDA device recall · Class II · Genzyme Diagnostics
Key facts
| Recall number (Z-number) | Z-0770-04 |
|---|---|
| Recall event | 28473 |
| Product | Giardia/ Cryptosporidium Rapid In-vitro diagnostic Test kits. These are sold under two names as follows: Meridian ImmunoCard Stat Cryptosporidium/Giardia Rapid Assay; Becton Dickenson (BD) ColorPac Giardia/Crypotsporidium Rapid Assay |
| Product code | MHI |
| Recalling firm | Genzyme Diagnostics |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 15, 2004 |
| 510(k) numbers | K983399 |
| FEI number | 1000520007 |
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