Drugs & medicalClass II

BioFire Diagnostics, LLC recalls BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic medium BD BACTEC Peds Plus medium BD…

Due to a trend in false positive Candida tropicalis results on blood culture panel when using certain BD BACTEC vial mediums

Read the official notice →
Date
2024-02-21
Country
United States
Brand
BioFire Diagnostics
Product
BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic medium BD BACTEC Peds Plus medium BD BACTEC…
Classification
Class II
Units
Worldwide - U.S. Nationwide distribution including in the states of AK, AL,…
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More BioFire Diagnostics recalls

  1. 2024-08-14
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    BioFire Diagnostics, LLC recalls BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF…

    Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium.

    FDA · DeviceBioFire Diagnostics, LLCU.S.: Nationwide - AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL,…Official notice →
  3. 2024-08-07
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    BioFire Diagnostics, LLC recalls BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in conjunction with Culture…

    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…

    FDA · DeviceBioFire Diagnostics, LLCWorldwide - US Nationwide distribution including in the states of FL, IL, KY,…Official notice →
  5. 2024-02-21
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    BioFire Diagnostics, LLC recalls FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gastrointestinal microorganism multiplex…

    Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel.

    FDA · DeviceBioFire Diagnostics, LLCWorldwide - U.S. Nationwide distribution in the states of AK, AL, AR, AZ, CA,…Official notice →
  7. 2024-02-14
  8. US
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    BioFire Diagnostics, LLC recalls FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit)

    Their is a potential for false positive results when using Pneumonia panel.

    FDA · DeviceBioFire Diagnostics, LLCWorldwide - US Nationwide distribution including in the states of AL, AR, AZ,…Official notice →
  9. 2024-01-17
  10. US
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    BioFire Diagnostics, LLC recalls The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with the BIOFIRE FILMARRAY 2.0…

    A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could lead to inappropriate antibiotic treatment, no treatment, delay of…

    FDA · DeviceBioFire Diagnostics, LLCUS: NC, MO, NE, CT, IL, TN, NJ, OH, MA, CA, FL, UT, IA, KS, TX, MDOfficial notice →
  11. 2023-12-13
  12. US
    Drugs & medicalClass II

    BioFire Diagnostics, LLC recalls BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, Inc (MMQCI)…

    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…

    FDA · DeviceBioFire Diagnostics, LLCWorldwide Distribution: US (nationwide): DE, OH, NY, IL, KY, FL, GA, KS, CA,…Official notice →
All 21 BioFire Diagnostics recalls →

Other drugs & medical recalls in the United States

  1. 2024-02-28
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