Device recall
Z-1111-2014: cobas PCR Urine Kit 100 PKT IVD cobas PCR Female Swab Kit 100 PKT IVD cobas PCR…
FDA device recall · Class II · Roche Molecular Systems, Inc.
Key facts
| Recall number (Z-number) | Z-1111-2014 |
|---|---|
| Recall event | 67441 |
| Product | cobas PCR Urine Kit 100 PKT IVD cobas PCR Female Swab Kit 100 PKT IVD cobas PCR media 100T IVD cobas PCR Female Swab Kit 100 PKT JPN-IVD Roche Molecular Systems, Inc. Branchburg, NJ 08876 USA Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 The cobas PCR media serves as a nucleic acid… |
| Product code | OOI |
| Recalling firm | Roche Molecular Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 7, 2014 |
| 510(k) numbers | K110923 |
| FEI number | 2243471 |
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