Lower riskMedical device recall · FDA · Published January 26, 2021
BioFire BCID Panels Risk False Pseudomonas Positives with Specific Blood Culture Vials
BioFire Diagnostics recalls Gram-Negative Bacteria Blood Culture Panels that may give false Pseudomonas aeruginosa results when used with certain BD BACTEC vials. Affected units include specific model numbers and lots.
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.
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Contact the company
📍Recalling firmBioFire Diagnostics, LLC515 S Colorow Dr · Salt Lake City, UT 84108-1248
✎ GovInfoNow plain-language explainer
BioFire Diagnostics recalls its Film Array Blood Culture Identification (BCID) panels because they can produce false positive results for Pseudomonas aeruginosa when used with specific BD BACTEC blood culture vials. This could lead to incorrect infection diagnoses and inappropriate treatment. Read more at govinfonow.com/recall/63346-biofire-bcid-panels-risk-false-pseudomonas-positives-with-specific-blood.
“BioFire BCID Panels Risk False Pseudomonas Positives with Specific Blood Culture Vials.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63346-biofire-bcid-panels-risk-false-pseudomonas-positives-with-specific-blood. Based on FDA recall #Z-1157-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1157-2021%22&limit=1).
The FDA announced on Jan. 26, 2021, that BioFire Diagnostics LLC is recalling Film Array BCID and BCID2 panels due to an increased risk of false positive results for Pseudomonas aeruginosa when used with specific BD BACTEC blood culture vials. The recall affects 21,922 kits distributed worldwide.
How to tell if you have it
Brand: BioFire
Product: Film Array Blood Culture Identification (BCID) and BCID2 Panels
Part No: RFIT-ASY-0126 / UDI: 00815381020086
Part No: RFIT-ASY-0127 / UDI: 00815381020093
Compatible Vials: BD BACTEC Culture Media vials Catalog No. 442023 and 442020
Quantity: 21,922 kits
The hazard
According to the FDA, the hazard is an increased risk of false positive Pseudomonas aeruginosa results. This occurs when the BCID or BCID2 panels are used with specific BD BACTEC blood culture vials.
Context
GovInfoNow's records show BioFire Diagnostics LLC has 32 other recalls on record since March 14, 2018. Recent BioFire recalls include a June 24, 2026 recall of the Respiratory Panel 2.1 for false negative results and an April 22, 2026 recall of the Joint Infection Panel for false positive risks. Other recent recalls of similar products include the Jan. 5, 2026 Biomerieux VITEK 2 Gram-negative Susceptibility Cards recall and the Dec. 24, 2025 Medline Blood Culture Kit recall.
How to tell if you have this one
Check for product model numbers RFIT-ASY-0126 or RFIT-ASY-0127 on the BCID panels. These panels were sold with BD BACTEC vials catalog numbers 442023 or 442020.
Brand
BioFire
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
Worldwide distribution - US Nationwide distribution and the countries of Afghanistan, Angola, Anguilla , Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Brazil, Brunei. Daruss., Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Czech Republic, Dominican Rep, Dutch Antilles, Ecuador, Egypt, El Salvador, Estonia, France, Georgia, Germany, Greece, Guam, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Japan, Jordan, Kenya, Kuwait, Latvia, Lebanon, Macedonia, Malaysia, Mexico, Morocco, Myanmar, Netherlands, Nicaragua, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Serbia, Singapore, Slovenia, South Korea, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Kingdom, Uruguay, Utd/Arab Emir/, Vietnam.
Recall number
Product, codes & lots
Quantity
Z-1157-2021
Gram-Negative Bacteria And Associated Resistance Markers; Film Array Blood Culture Identification (BCID); Film Array BCID Panel - Product Usage: intended for use with FilmArray systems. Part No: RFIT-ASY-0126 / UDI: 00815381020086 Part No: RFIT-ASY-0127 / UDI: 00815381020093 IVD, Rx Only; All non-expired BCID and BCID2 Panel lots, if used with the BD BACTEC Culture Media vials Catalog No. 442023 and 442020.
21,922 kits
Z-1158-2021
BioFire BCID2 Panel; IVD, Rx Only Part No: RFIT-ASY-0147 / UDI: 00815381020338 - Product Usage: intended for use with FilmArray systems.; All non-expired BCID and BCID2 Panel lots, if used with the BD BACTEC Culture Media vials Catalog No. 442023 and 442020.
5,220 kits
Based on the official FDA remedy
What to do — step by step
Check Panel Model
Identify if your BCID panel has model numbers RFIT-ASY-0126 or RFIT-ASY-0127.
Verify Vial Type
Confirm if you're using BD BACTEC vials with catalog numbers 442023 or 442020.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution and the countries of Afghanistan, Angola, Anguilla , Argentina, Australia, Austria, Bahrain, Belarus, Belgium, Bolivia, Brazil, Brunei. Daruss., Bulgaria, Canada, Chile, China, Colombia,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 15 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1157-2021 (January 26, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1157-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.