Z-0296-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 7, 2018
- Initiation Date
- September 5, 2018
- Termination Date
- March 22, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18038
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.
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
Code Information
All lots.