BioFire Diagnostics, LLC — FDA Facility Profile
BioFire Diagnostics, LLC is an FDA-registered facility (FEI 3002773840) located in Salt Lake City, UT, US. RegDataLab tracks 5 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Apr 5, 2024: No Action Indicated (NAI)
- Inspections on record
- 5 (5 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Recalls as the recalling firm
- 35, latest Aug 12, 2026
- Import refusals
- 2
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Apr 5, 2024 | No Action Indicated (NAI) | Evaluation, timeliness, identification (21 CFR 820.198(d)) |
| Aug 5, 2021 | No Action Indicated (NAI) | No citations listed |
| Mar 18, 2016 | No Action Indicated (NAI) | No citations listed |
| Oct 18, 2012 | No Action Indicated (NAI) | No citations listed |
| Aug 5, 2010 | No Action Indicated (NAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Periodic equipment inspections (21 CFR 820.70(g)(2)) Quality Audits - defined intervals (21 CFR 820.22) |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Aug 12, 2026 | Class II | Z-0148-2027 | Generic Name: FilmArray¿ Pneumonia Panel
Generic Name: FilmArray¿ Pneumonia… and 2 more products Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results |
| Jun 24, 2026 | Class II | Z-2936-2026 | BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742
UDI code: 00815381020529
PCR-based… Due to increase in false negative results |
| Apr 22, 2026 | Class II | Z-2067-2026 | BioFire Joint Infection (JI) Panel
REF: RFIT-ASY-0138, 30 test Kit. Contamination to in-vitro diagnostic test may result in false positives. |
| Apr 1, 2026 | Class II | Z-2081-2026 | Biofire Spotfire Respiratory/Sore Throat Panel
REF: 423485 Respiratory/sore throat panel test may result in false negative results and control failures. |
| Oct 22, 2025 | Class II | Z-0602-2026 | BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit) Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control… |
| Apr 30, 2025 | Class II | Z-1877-2025 | BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results. |
| Feb 27, 2025 | Class II | Z-1518-2025 | FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374 Increased risk of control failures and false negative test results with multiplexed nucleic acid test. |
| Aug 7, 2024 | Class II | Z-3122-2024 | FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W and 1 more product Some automated in vitro diagnostic modules and instruments manufactured or serviced between May 2022 and May 2024 were calibrated with… |
| Jun 19, 2024 | Class II | Z-2456-2024 | BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY… If blood culture identification panel is used in conjunction with specific lots of culture media bottles, then false positive Serratia… |
| Jun 10, 2024 | Class II | Z-2682-2024 | BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144 and 1 more product Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing process, which could lead to delayed… |
Facility details
- Company
- BioFire Diagnostics, LLC
- Location
- Salt Lake City, UT (US)
- Source
- device