Device recall
Z-1157-2021: Gram-Negative Bacteria And Associated Resistance Markers; Film Array Blood…
FDA device recall · Class II · BioFire Diagnostics, LLC
Key facts
| Recall number (Z-number) | Z-1157-2021 |
|---|---|
| Recall event | 87282 |
| Product | Gram-Negative Bacteria And Associated Resistance Markers; Film Array Blood Culture Identification (BCID); Film Array BCID Panel - Product Usage: intended for use with FilmArray systems. Part No: RFIT-ASY-0126 / UDI: 00815381020086 Part No: RFIT-ASY-0127 / UDI: 00815381020093 IVD, Rx Only |
| Product code | PEN |
| Recalling firm | BioFire Diagnostics, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 2, 2022 |
| 510(k) numbers | K181493 |
| FEI number | 3002773840 |
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