BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in conjunctio
Summary
The FDA issued a Class II for BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FI by BioFire Diagnostics, LLC. Reason: If blood culture identification panel is used in conjunction with specific lots of culture media bottles, then false positive Serratia marcescens resu.
Details
Source
Device Recall
External ID
Z-2456-2024
Action Date
2024-08-07
Status
Ongoing
Category
device
Product Description
BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in conjunction with Culture Media Bottles: BACT/ALERT FA PLUS, REF: 410851, and BACT/ALERT PF PLUS, REF: 410853
Lot/Code Info: BCID2 Panel REF: RFIT-ASY-0147, UDI-DI: 00815381020338, All unexpired lots. BACT/ALERT REF/UDI-DI: Lot/Expiration: 410851/03573026596057: 0004101638/3/20/2024, 0004101930/7/28/2024, 0004102026/9/4/2024, 0004102408/2/16/2025, 0004102996/9/24/2025, 0004102946/8/29/2025, 0004102956/9/17/2025, 0004102998/9/24/2025. 410853/03573026596095: 0004101718/4/24/2024, 0004101790/6/1/2024, 0004101958/8/3/2024, 0004102452/3/3/2025, 0004102964/9/19/2025
Quantity Affected: 99,822
Reason for Recall
If blood culture identification panel is used in conjunction with specific lots of culture media bottles, then false positive Serratia marcescens results may occur, due to an increased level of non-viable organism from serratia marcescens targets in culture media bottles, false positive result may lead to an inappropriate change in patient therapy.
Distribution
Worldwide - US Nationwide distribution including in the states of FL, IL, KY, CO, KS, NC, AK, NY, ND, CA, TX, MD, GA, OH, WI, SD, LA, MT, VA, IA, MO, MA, WV, NE, OK, AZ, OR, SC, MI, IN, ID, TN, WA, NM, NJ, AR, AL, MN, NH, NV, PA, WY, MS, CT and the countries of AE, AM, AR, AT, BA, BG, BH, BN, BR, CA, CH, CI, CK, CN, CO, CZ, DE, DZ, EC, EE, EG, ES, FI, FR, GA, GB, GE, GR, GT, HR, HU, IL, IN, IQ, IS, IT, JO, JP, KK, KR, KW, LB, LT, LV, MK, MM, MX, MY, NG, NO, NW, OM, PA, PH, PK, PL, PT, QA, RO, RS, SA, SI, TN, TR, TW, UG, UY, VN, WF.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-06-19
Company
Salt Lake City, UT
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 107 device recalls issued in the same week, part of 403 device-related FDA actions this month.
BioFire Diagnostics, LLC has 41 FDA actions in our database, including 30 recalls and 11 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (BioFire Diagnostics, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does BioFire Diagnostics, LLC have FDA actions?
BioFire Diagnostics, LLC has 41 FDA actions in our database, including 30 recalls and 11 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2456-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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