Z-2456-2024Class II

BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in...

Name: Z-2456-2024 BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in...
Creator: BioFire Diagnostics, LLC
Published: 2024-06-19
License: https://open.fda.gov/license/

BioFire Diagnostics, LLC / initiated 2024-06-19 / Open, Classified / root cause: design

FDA source

BioFire Diagnostics, LLC began a recall of BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in conjunction with Culture Media Bottles... on 2024-06-19. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2456-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-06-19
Posted: 2024-07-31
Recalling firm: BioFire Diagnostics, LLC
Product: 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
Product code: PEN Gram-Negative Bacteria And Associated Resistance Markers
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.
Root cause tag: design
FDA root cause: Device Design
Action: On 06/19/24, recall notices were distributed to laboratory managers who were informed the following: 1) Positive results for Serratia marcescens should be confirmed by another method prior to reporting the test results. 2) Distribute this information to all appropriate personnel in your laboratory, retain a copy in your files, post this letter in or near the laboratory, and forward this information to all parties that may use this product, including others to whom you may have transferred our product. 3) Complete and return the acknowledgement form via email to [email protected] If you require additional assistance or have any questions, please contact firm's US Commercial Operations. at (800) 682-2666. For non-urgent inquiries, please contact the Technical Support Center by email at [email protected]. The anticipated turnaround time for email inquiries is 24 - 48 hours during normal business hours. On 11/04/24, additional notices were sent to customers informing them of three additional affected lots. On 2/3/2025, additional notices were sent to customers informing them of one additional affected lot. On 6/3/2025, additional notices were sent to customers informing them of five additional affected lots.
Quantity in commerce: 99,822
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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2456-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2456-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-08-07	2024-07-31

Product code PEN

K193519Class IIBioFire Blood Culture Identification 2 (BCID2) PanelBiofire Diagnostics, LLC / cleared 2020-03-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)