Drugs & medicalClass II

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.

Read the official notice →
Date
2024-08-14
Country
United States
Brand
BioFire Diagnostics
Product
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF…
Classification
Class II
Units
U.S.: Nationwide - AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL,…
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 Details may be shortened or out of date; the official notice is the authoritative source.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

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  3. 2024-09-18
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  5. 2024-08-28
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  7. 2024-08-07
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    FDA · DeviceBioFire Diagnostics, LLCWorldwide - US Nationwide distribution including in the states of FL, IL, KY,…Official notice →
  9. 2024-02-21
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    FDA · DeviceBioFire Diagnostics, LLCWorldwide - U.S. Nationwide distribution in the states of AK, AL, AR, AZ, CA,…Official notice →
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All 21 BioFire Diagnostics recalls →

Other drugs & medical recalls in the United States

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    An issue with safe usage of the device was identified whereby toxic smoke and internal fire developed resulting from a problem associated with the sealing of the paraffin tank.

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