Device recall
Z-1318-2010: Access Immunoassay Systems Accu Tnl Reagent Kit when used in conjunction with…
FDA device recall · Class II · Beckman Coulter Inc.
Key facts
| Recall number (Z-number) | Z-1318-2010 |
|---|---|
| Recall event | 54729 |
| Product | Access Immunoassay Systems Accu Tnl Reagent Kit when used in conjunction with UniCel Dxl Access Immunoassay Systems; Reagent Part Numbers: A78803 & 33340; Calibrator Part Number: 33345 The intended use: The Access AccuTnI assay is a paramagnetic particle, chemiluminescent immunoassay for the… |
| Product code | MMI |
| Recalling firm | Beckman Coulter Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 9, 2012 |
| 510(k) numbers | K010429, K021814 |
| FEI number | 2050012 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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