Device product
FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID Panel Part No: RFIT-ASY-0126 Part No: RFIT-ASY-0127
Z-2245-2021
Product summary
- Event
- Event 88410
- Status
- Terminated
- Classification
- Class II
- Quantity
- 29 kits
- Official record key
device-enforcement:Z-2245-2021
Official wording
Reason: Due to product complaints received for false negative results (dropouts) with blood culture identification panel potential caused by a pouch manufacturing error.
Code information: Part No: RFIT-ASY-0126 / UDI: 00815381020086; Part No: RFIT-ASY-0127 / UDI: 00815381020093; Kit Lot# 0868221; Pouch Lot# 194Z21; Batch 003
Distribution pattern: U.S. Nationwide Distribution in the states of : FL, MI, NJ, OH, VA and WI. O.U.S.: None
Derived failure modes
-
Manufacturing or process control
manufacturing error