CLASS II ONGOING Device recall · Reported 13 Dec 2023 · FDA Enforcement Report

Biofire Blood Culture Identification 2 (BCID2) Panel recalled

BioFire Diagnostics is recalling Biofire Blood Culture Identification 2 (BCID2) Panel, distributed nationwide in the US. The recall was initiated on 17 Oct 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesREF/UDI-DI: RFIT-ASY-0147/00815381020338. FLM1-PRT-0251-16 and prior.

Quantity recalled32,910

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-0451-2024
FDA event ID: 93360
Recalling firm: BioFire Diagnostics, Salt Lake City, UT
Classification: Class II
Status: Ongoing
Recall initiated: 17 Oct 2023
FDA classified: 1 Dec 2023
Reported: 13 Dec 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Other Medical Devices

Timeline

17 Oct 2023	Recall initiated by company
1 Dec 2023	Classified by FDA	+45 days
13 Dec 2023	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Routine quality control testing of affected blood culture identification panel with affected control panel may need to be amended, due to control panel/instrument characteristic changes, that lead C. tropicalis to be amplified in some portion of test runs, but then it's reported as "Not Detected" because the assay amplicon Tm is outside the acceptable limit assigned for calling positive results.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, Inc (MMQCI) FilmArray BCID2 Control Panel M416, which is referenced in Quality Control Materials for use with BIOFIRE FILMARRAY and BIOFIRE SPOTFIRE Panels - FLM1-PRT-0251

Where it was distributed

Worldwide Distribution: US (nationwide): DE, OH, NY, IL, KY, FL, GA, KS, CA, WI, NC,, AK, PA, MN, ND, IN, AR, CO, UT, TX, AL, NJ, MD, SD, LA, OR, MA, ID, NE, MT, VA, IA, MO, WV, TN, MI, WY, SC, AZ, WA, NH, OK, HI, MS, DC, VT, CT, NM, RI, ME, NV; and OUS (foreign) to countries of: Algeria, Angola, Armenia, Bahrain, Bolivia, Bosnia- Herzegovina, Brunei, Bulgaria, Costa Rica, Croatia, Cyprus, Dominican Republic, Dutch Antilles, Ecuador, El Salvador, Estonia, Gabon, Georgia, Guam, Guatemala, Honduras, Indonesia, Ireland, Iceland, Israel, Ivory Coast, Jordan, Kosovo, Kuwait, Latvia, Lebanon, Lithuania, Macao, Macedonia, Malaysia, Mali, Mongolia, Morocco, New Zealand, Nicaragua, Oman, Pakistan, Panama, Paraguay, Peru, Qatar, Romania, Saudi Arabia, Serbia , Slovenia, Tunisia, Uganda, United Arab Emirate, Uruguay, Venezuela, Vietnam, Zimbabwe, Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Spain, France, United Kingdom, Greece, India, Italia, Japan, Korea, Netherlands, Poland, Portugal, Sweden, Singapore, Thailand, Turkey, Taiwan, Switzerland, Austria, Denmark, Finland, Germany, Belgium, Hungary, South Africa, Philippines, Norway, Mexico

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts

Questions about this recall

Why was it recalled?

Which lots are affected?

REF/UDI-DI: RFIT-ASY-0147/00815381020338. FLM1-PRT-0251-16 and prior.

Where was it sold?

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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