Device recall
Z-0352-2007: ADVIA 1650 Chemistry System, Automated Clinical Chemistry Analyzer - human…
FDA device recall · Class II · Bayer Healthcare, LLC (Diagnostics Division)
Key facts
| Recall number (Z-number) | Z-0352-2007 |
|---|---|
| Recall event | 36713 |
| Product | ADVIA 1650 Chemistry System, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests. The following are the measured parameters that are within the scope of this ''field correction'': Affected assay: Valproic Acid. Affecting assays: Digoxin; Phenytoin; Gentamicin; Theophylline. |
| Product code | LEG |
| Recalling firm | Bayer Healthcare, LLC (Diagnostics Division) |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 23, 2012 |
| 510(k) numbers | K990346 |
| FEI number | 2432235 |
At a glance
- 1–9 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