Device recall
Z-1645-2012: Access Hybritech Free PSA, Part Number: 37210 Free PSA is used to aid in the…
FDA device recall · Class III · Beckman Coulter Inc.
Key facts
| Recall number (Z-number) | Z-1645-2012 |
|---|---|
| Recall event | 61770 |
| Product | Access Hybritech Free PSA, Part Number: 37210 Free PSA is used to aid in the differentiation between prostate cancer and benign prostatic conditions when total PSA levels are between 4 and 10 ng/mL. |
| Product code | MTG |
| Recalling firm | Beckman Coulter Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Mar 18, 2013 |
| FEI number | 2050012 |
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