Recall Z-1513-2018— BioFire Diagnostics, LLC
Class II · Terminated
Class II FDA medical device recall by BioFire Diagnostics, LLC, initiated 2018-03-14, terminated 2018-10-24. It names 3 FDA 510(k) clearances: K160457, K143171, K130914. Product: FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126 (30 test kit) and RFIT-ASY-0127 (6 test kit), when used with all lots of BD BACTEC Blood Culture Bottles, Catalog numbers 442020, 442021, 442023, 442192, 442265, 442194, 442022, 442193, 442260, and 442191.. Reason: There is an increased risk of false positive Proteus results when the product is used with specific types of BD BACTEC blood culture bottles..
- Recalling firm
- BioFire Diagnostics, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-03-14
- Terminated
- 2018-10-24
- Firm location
- Salt Lake City, UT, United States
510(k) clearances named in this recall
3 on FDA's record- K160457 — FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch
- K143171 — FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0
- K130914 — FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126 (30 test kit) and RFIT-ASY-0127 (6 test kit), when used with all lots of BD BACTEC Blood Culture Bottles, Catalog numbers 442020, 442021, 442023, 442192, 442265, 442194, 442022, 442193, 442260, and 442191.
Reason for recall
There is an increased risk of false positive Proteus results when the product is used with specific types of BD BACTEC blood culture bottles.
Data sourced from openFDA. This site is unofficial and independent of the FDA.