CLASS II ONGOING Device recall · Reported 20 Sep 2023 · FDA Enforcement Report
Filmarray Gastrointestinal (GI) Panel recalled by BioFire Diagnostics
BioFire Diagnostics is recalling Filmarray Gastrointestinal (GI) Panel (, distributed in 52 states. The recall was initiated on 25 Apr 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2588-2023
- FDA event ID
- 92885
- Recalling firm
- BioFire Diagnostics, Salt Lake City, UT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Apr 2023
- FDA classified
- 14 Sep 2023
- Reported
- 20 Sep 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 25 Apr 2023 | Recall initiated by company | |
| 14 Sep 2023 | Classified by FDA | +142 days |
| 20 Sep 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The firm has identified an increased risk of obtaining false positive Cryptosporidium results from customers using the BIOFIRE¿ FILMARRAY¿ Gastrointestinal (GI) Panel
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software
Where it was distributed
US:DE, AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, 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, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY. OUS: AD, AE, AI, AR, AT, AU, BD, BE, BF, BG, BH, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DZ, EE, ES, FI, FR, GA, GB, GE, GH, GM, GR, GU, HK, HU, IC, ID, IE, IL, IN, IQ, IT, JP, KE, KR, KW, LV, MO, MX, MY, NL, NO, NP, NZ, PG, PH, PL, PT, QA, RS, SA, SE, SG, SI, TH, TN, TR, TW, VN, ZA, ZW
AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusetts
Questions about this recall
Why was it recalled?
The firm has identified an increased risk of obtaining false positive Cryptosporidium results from customers using the BIOFIRE¿ FILMARRAY¿ Gastrointestinal (GI) Panel
Which lots are affected?
Model/UDI-DI: RFIT-ASY-0104/00815381020116, RFIT-ASY-0116/00815381020109 using software versions prior to FLM2-SFW-0040 v2.0.3.1/BFS0001-5539 v2.0.200.10
Where was it sold?
US:DE, AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, 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, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY. OUS: AD, AE, AI, AR, AT, AU, BD, BE, BF, BG, BH, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DZ, EE, ES, FI, FR, GA, GB, GE, GH, GM, GR, GU, HK, HU, IC, ID, IE, IL, IN, IQ, IT, JP, KE, KR, KW, LV, MO, MX, MY, NL, NO, NP, NZ, PG, PH, PL, PT, QA, RS, SA, SE, SG, SI, TH, TN, TR, TW, VN, ZA, ZW
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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