Device recall
Z-0162-2013: Siemens ADVIA Centaur BR Assay: Catalog Number: US: REF 02419937 (10214722) (50…
FDA device recall · Class II · Siemens Healthcare Diagnostics, Inc
Key facts
| Recall number (Z-number) | Z-0162-2013 |
|---|---|
| Recall event | 63167 |
| Product | Siemens ADVIA Centaur BR Assay: Catalog Number: US: REF 02419937 (10214722) (50 Tests); REF 03896216(10334837)(250 Tests) Not CE Marked; OUS: REF03204829(10310271)(50 Tests); REF 01157807(1 0314722) (250 Tests) CE Marked; REF 09010686 (10340081)(250 Tests). The ADVIA Centaur BR assay is an in vitro… |
| Product code | MOI |
| Recalling firm | Siemens Healthcare Diagnostics, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 1, 2016 |
| 510(k) numbers | K982680 |
| FEI number | 1219913 |
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