Device recall
Z-2243-2010: Human Cardiac Specific Fatty Acid-Binding Protein (H-FABP) ELISA TEST KIT…
FDA device recall · Class II · BioCheck Inc
Key facts
| Recall number (Z-number) | Z-2243-2010 |
|---|---|
| Recall event | 56291 |
| Product | Human Cardiac Specific Fatty Acid-Binding Protein (H-FABP) ELISA TEST KIT Product is an In Vitro Device (IVD) categorized as a Cardiac Marker, manufactured and distributed by BioCheck, Inc., Foster City, CA. Enzyme Immunoassay for the quantitative determination of Human Cardiac Fatty Acid-Binding… |
| Product code | NUK |
| Recalling firm | BioCheck Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 13, 2010 |
| FEI number | 3002564473 |
At a glance
- None 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