Device recall
Z-0327-06: Vitros Immunodiagnostic HBsAg CONFIRMATORY KIT * REF 680 1324. Firm on label…
FDA device recall · Class I · Ortho-Clinical Diagnostics
Key facts
| Recall number (Z-number) | Z-0327-06 |
|---|---|
| Recall event | 34238 |
| Product | Vitros Immunodiagnostic HBsAg CONFIRMATORY KIT * REF 680 1324. Firm on label: Ortho-Clinical Diagnostics, 62 The Broadway, Amersham, Bucks, UK. UPC *+H221680132412* . Each kit contains: 1 x kit of reagents, and protocol card for HBsAg Confirmatory Kit. According to the firm (but not on label), there… |
| Product code | LOM |
| Recalling firm | Ortho-Clinical Diagnostics |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Aug 7, 2007 |
| FEI number | 1000136573 |
At a glance
- None 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