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BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF:… recallZ-2456-2024 · BioFire Diagnostics, LLC · initiated Jun 19, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from BioFire Diagnostics, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-2456-2024
Status
Open, Classified
Initiated by the company
Jun 19, 2024
Posted by the FDA
Jul 31, 2024
Recalling firm
BioFire Diagnostics, LLC
Quantity
99,822
Product code
PEN
FDA submissions
K193519
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 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

Code information (models, lots, serial numbers)

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

Devices named in this recall

3 devices in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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