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,
Reported: November 7, 2018 Initiated: September 5, 2018 #Z-0296-2019
Product Description
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,
Reason for Recall
Increased risk of false positive results for Proteus when the product is used with a specific blood culture bottles.
Details
- Recalling Firm
- BioFire Diagnostics, LLC
- Units Affected
- 18038
- Distribution
- Worldwide distribution. US nationwide, Kuwait, Lebanon, Malaysia, Myanmar, Nicaragua, Oman, Panama, Paraguay, Peru, Philippines, Qatar, Romania, Saudi Arabia, Slovenia, Uruguay, United Arab Emirates, Vietnam
- Location
- Salt Lake City, UT
Frequently Asked Questions
What product was recalled? ▼
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,. Recalled by BioFire Diagnostics, LLC. Units affected: 18038.
Why was this product recalled? ▼
Increased risk of false positive results for Proteus when the product is used with a specific blood culture bottles.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 7, 2018. Severity: Moderate. Recall number: Z-0296-2019.
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