Device recall
Z-2237-2021: Advance Dx 100 Blood Collection Card Quantity 25 REF CMT01 Advance Dx 100 Blood…
FDA device recall · Class II · Advance Dx, Inc.
Key facts
| Recall number (Z-number) | Z-2237-2021 |
|---|---|
| Recall event | 88281 |
| Product | Advance Dx 100 Blood Collection Card Quantity 25 REF CMT01 Advance Dx 100 Blood Collection Card and Foil Bags Quantity 500 Cards and Foil Bags REF CMT01/F02 IFU: Advance Dx 100 SSE(Serum Separating Extraction) Technology BLOOD COLLECTION INSTRUCTIONS |
| Product code | JKA |
| Recalling firm | Advance Dx, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 22, 2023 |
| FEI number | 3006457763 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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