Z-0296-2019 Class II Terminated
FDA device recall Z-0296-2019 was initiated by BioFire Diagnostics, LLC on Sep 5, 2018 and is designated Class II. Reason for recall: Increased risk of false positive results for Proteus when the product is used with a specific blood culture bottles. The recall status is terminated (terminated Mar 22, 2021). Affected quantity: 18038.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 7, 2018
- Initiation Date
- Sep 5, 2018
- Termination Date
- Mar 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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0296-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026