510(k) · Cleared
Recalled · Class II · 2021FilmArray Blood Culture Identification (BCID) Panel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biofire Diagnostics, LLC · PEN Gram-Negative Bacteria And Associated Resistance Markers
Cleared on Jul 5, 2018 after a 29-day review. The FDA summary names no predicate by number. 2 later devices descend from it. It has been recalled 6 times.
- Decided
- Jul 5, 2018
- Review
- 29 days
- Class
- Class II
- Product code
- PEN
- Recalls
- 6
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK181493 FilmArray Blood Culture Identification (BCID) PanelBiofire Diagnostics, LLC · 2018
- Descendant · cites it directly · 1 of its ownK193519 BioFire Blood Culture Identification 2 (BCID2) PanelBiofire Diagnostics, LLC · 2020 · Recalled
- Descendant · 2 generations on · 0 of its ownK243759 BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147…Biofire Diagnostics, LLC · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K181493 | FilmArray Blood Culture Identification (BCID) Panel | Biofire Diagnostics, LLC | 2018 | — |
| +1 | K193519 | BioFire Blood Culture Identification 2 (BCID2) Panel | Biofire Diagnostics, LLC | 2020 | 7 |
| +2 | K243759 | BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack)… | Biofire Diagnostics, LLC | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PEN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PEN device
- #1 K262168 QIAstat-Dx BCID GN Plus AMR Panelscore 12.1 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193519 | BioFire Blood Culture Identification 2 (BCID2) Panel | 2020 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 20, 2021 | Class II | Z-2245-2021 | Process control | 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 | Other | 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 | Under Investigation by firm | 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 specific media types. False positive… |
| Jan 22, 2020 | Class II | Z-2295-2020 | Under Investigation by firm | 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 specific media types. False positive… |
| Mar 7, 2019 | Class II | Z-1133-2019 | Material/Component Contamination | 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 | Material/Component Contamination | Increased risk of false positive results for Proteus when the product is used with a specific blood culture bottles. |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K193519 (Biofire Diagnostics, LLC, 2020) has gone furthest, with 1 descendant of its own.
How does its category compare?
All PEN devicesPEN Gram-Negative Bacteria And Associated Resistance Markers: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · PEN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PEN
Too few PEN 510(k)s in any year since 2007 to give a median.
Recalls per year · PEN
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PEN
13in 2025
MAUDE reports naming product code PEN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 5 |
| 2020 | 1 | — | 1 | 4 |
| 2021 | 0 | — | 1 | 15 |
| 2022 | 1 | — | 0 | 5 |
| 2023 | 0 | — | 1 | 1 |
| 2024 | 1 | — | 0 | 8 |
| 2025 | 1 | — | 0 | 13 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K181493 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181493: FilmArray Blood Culture Identification (BCID) Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181493
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026