# K181493: FilmArray Blood Culture Identification (BCID) Panel

- Pathway: 510(k) (Special)
- Applicant: Biofire Diagnostics, LLC
- Decided: Jul 5, 2018 after 29 days
- Product code: PEN (Gram-Negative Bacteria And Associated Resistance Markers)
- Device class: 2
- Regulation: 21 CFR 866.3365
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K193519: BioFire Blood Culture Identification 2 (BCID2) Panel (2020), 1 descendant of its own
- K243759: BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack)) (2024), 0 descendants of its own

## Recalls of this device
- Jul 20, 2021 · Class II · Z-2245-2021: Due to product complaints received for false negative results (dropouts) with blood culture identification panel potential caused by a pouch manufacturing error.
- Jan 26, 2021 · Class II · Z-1157-2021: The firm has identified an increased risk of false positive Pseudomonas aeruginosa when BCID/BCID2 Panels are used with specific BD BACTEC" blood culture vials.
- Jan 22, 2020 · Class II · Z-2296-2020: There is an increased risk of false positive Proteus results when using the Film Array Blood Culture Identification Panel (BCID) in vitro diagnostic test of blood cultures used in conjunction with spe
- Jan 22, 2020 · Class II · Z-2295-2020: There is an increased risk of false positive Proteus results when using the Film Array Blood Culture Identification Panel (BCID) in vitro diagnostic test of blood cultures used in conjunction with spe
- Mar 7, 2019 · Class II · Z-1133-2019: Increased risk of false positive Enterobacteriaceae and Escherichia coli results on affected blood culture identification panels when using certain blood culture bottles.
- Sep 5, 2018 · Class II · Z-0296-2019: Increased risk of false positive results for Proteus when the product is used with a specific blood culture bottles.

Source page: https://510kreport.com/device/K181493
Methodology: https://510kreport.com/methodology