Device recall
Z-2047-2013: PSA Assays for use in the IMMULITE/IMMULITE 1000 Systems Analyzers, Catalog…
FDA device recall · Class II · Siemens Healthcare Diagnostics
Key facts
| Recall number (Z-number) | Z-2047-2013 |
|---|---|
| Recall event | 65609 |
| Product | PSA Assays for use in the IMMULITE/IMMULITE 1000 Systems Analyzers, Catalog Numbers LKPS1, LKPS5 and LKPTS1(D); and in the IMMULITE 2000/2000XPi Systems Analyzers, Catalog Numbers L2KPS2, L2KPS6, L2KPTS2(D) and L2KPTS6(D). IVD Immunoassay kits in the following sizes: 100, 200, 500 and 600 test kits… |
| Product code | MFT |
| Recalling firm | Siemens Healthcare Diagnostics |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 28, 2017 |
| PMA numbers | P930027 |
| FEI number | 2432235 |
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