Device recall
Z-1316-2012: VITROS Chemistry Products --- dHDL Slides --- Ortho Clinical Diagnostics, a…
FDA device recall · Class II · Ortho-Clinical Diagnostics
Key facts
| Recall number (Z-number) | Z-1316-2012 |
|---|---|
| Recall event | 61222 |
| Product | VITROS Chemistry Products --- dHDL Slides --- Ortho Clinical Diagnostics, a Johnson&Johnson company --- [Mfg Symbol] Ortho-Clinical Diagnostics, Inc., Rochester, NY USA --- VITROS dHDL Slides are used to quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma using VITROS… |
| Product code | LBS |
| Recalling firm | Ortho-Clinical Diagnostics |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 5, 2018 |
| 510(k) numbers | K042006 |
| FEI number | 1000136573 |
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