BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobi...
FDA Device Recall #Z-1139-2024 — Class II — January 26, 2024
Recall Summary
| Recall Number | Z-1139-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 26, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | BioFire Diagnostics, LLC |
| Location | Salt Lake City, UT |
| Product Type | Devices |
| Quantity | 32,910 panels/pouches |
Product Description
BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic medium BD BACTEC Peds Plus medium BD BACTEC Plus Aerobic medium BD BACTEC Plus Anaerobic medium BD BACTEC Standard Aerobic medium BD BACTEC Standard Anaerobic medium The BIOFIRE Blood Culture Identification 2 (BCID2) Panel is a multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures.
Reason for Recall
Due to a trend in false positive Candida tropicalis results on blood culture panel when using certain BD BACTEC vial mediums
Distribution Pattern
Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Andorra, United Arab Emirates, Armenia, Argentina, Austria, Australia, Bosnia, Belgium, Bulgaria, Bahrain, Brunei, Bolivia, Brazil, Canada, Switzerland, Cote D'Ivoire, Chile, China, Colombia, Costa Rica, Cyprus, Cech Republic, Germany, Denmark, Dominican Republic, Algeria, Ecuador, Estonia, Egypt, Spain, Finland, France, Gabon, United Kingdom, Georgia, Guadeloupe, Greece, Guatemala, Hong Kong, Honduras, Croatia, Hungary, Iceland, Indonesia, Ireland, Israel, India, Italy, Jordan, Japan, Korea, Kuwait, Lebanon, Lithuania, Latvia, Morocco, Macedonia, Mali, Mongolia, Macau, Mexico, Malaysia, New Caledonia, Nigeria, Nicaragua, Netherlands, Norway, New Zealand, Oman, Panama, Peru, French Polynesia, Philippines, Pakistan, Poland, St. Pierre/Miquelon, Portugal, Paraguay, Qatar, Reunion, Romania, Serbia, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, El Salvador, Thailand, Tunisia, Turkey, Taiwan, Uganda, Uruguay, Vatican City, Venezuela, Vietnam, South Africa, and Zimbabwe.
Lot / Code Information
For BioFire Blood Culture Identification 2 (BDID2) Panel Part Number: RFIT-ASY-0147 UDI-DI code: 00815381020338 Lot Numbers: All non-expired BCID2 Panel lots, if used with the BD BACTEC vials including but not limited to, the bottle types listed in Table 1. NOTE: The affected blood culture vial types most likely contain non-viable Candida tropicalis nucleic acid/DNA fragments that can be detected by the BCID2 Panel. Therefore, all lots of the BioFire BCID2 Panel would be affected if they are used with the affected blood culture vials. Neither the BioFire BCID2 test kits nor the BD BACTEC vials have a defect - both products are performing as intended.
Other Recalls from BioFire Diagnostics, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0602-2026 | Class II | BioFire Respiratory Panel 2.1, IVD, REF: 423742... | Oct 22, 2025 |
| Z-1877-2025 | Class II | BioFire Respiratory Panel 2.1 plus Kit, REF: 42... | Apr 30, 2025 |
| Z-1518-2025 | Class II | FilmArra Pneumonia Panel plus (Pneumoplus), REF... | Feb 27, 2025 |
| Z-3122-2024 | Class II | FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, F... | Aug 7, 2024 |
| Z-3123-2024 | Class II | FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA... | Aug 7, 2024 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.