Device recall
Z-0446-2019: -Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray Meningitis/Encephalitis (ME)…
FDA device recall · Class II · BioFire Diagnostics, LLC
Key facts
| Recall number (Z-number) | Z-0446-2019 |
|---|---|
| Recall event | 81197 |
| Product | -Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray Meningitis/Encephalitis (ME) Panel REF RFIT-ASY-0118 30 For FilmArray systems LOT KIT UDI (01)00815381020123 CE 0086 IVD -Fitment Label (P/N RFIT-LBL-0138) which identifies the pouch label - FilmArray ME Panel v1.4 LOT SN CE 0086 IVD Product Usage: The… |
| Product code | PLO |
| Recalling firm | BioFire Diagnostics, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 28, 2021 |
| FEI number | 3002773840 |
At a glance
- None 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