Device product
FilmArray Blood Culture Identification (BCID), IVD, Rx Only, BioFire Diagnostics, LLC, Panel Catalog Numbers/ UDI: RFIT-ASY-0126 (30 test kit)/ 00815381020086, RFIT-ASY-0127 (6 test kit)/ 00815381020093, when used with the following blood culture bottles: Bottle Description/Part Number: BACT/ALERT FA Plus/ 410851, BACT/ALERT FN Plus/ 410852, BACT/ALERT PF Plus/ 410853,
Z-0296-2019
Product summary
- Event
- Event 81060
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18038
- Official record key
device-enforcement:Z-0296-2019
Official wording
Reason: Increased risk of false positive results for Proteus when the product is used with a specific blood culture bottles.
Code information: All lots.
Distribution pattern: Worldwide distribution. US nationwide, Kuwait, Lebanon, Malaysia, Myanmar, Nicaragua, Oman, Panama, Paraguay, Peru, Philippines, Qatar, Romania, Saudi Arabia, Slovenia, Uruguay, United Arab Emirates, Vietnam
Derived failure modes
-
Unknown
Increased risk of false positive results for Proteus when the product is used with a specific blood culture bottles.