Device recall
Z-1215-2013: BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack, REF…
FDA device recall · Class II · Becton Dickinson & Co.
Key facts
| Recall number (Z-number) | Z-1215-2013 |
|---|---|
| Recall event | 64444 |
| Product | BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack, REF 441124, contains 12 each Microwells labeled in part ***BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack REF 441124 ***For use with the BD Viper System *** Becton, Dickinson and Company 7 Loveton… |
| Product code | JTY |
| Recalling firm | Becton Dickinson & Co. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 13, 2013 |
| 510(k) numbers | K081825, K090827, K090971, K091730 |
| FEI number | 1119779 |
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