Medical Device Correction Notice: BIOFIRE FILMARRAY TORCH System – Increased Risk of Power Short

This electronic form is to confirm acknowledgement of the Medical Device Correction Notice that was mailed to BIOFIRE FILMARRAY TORCH customers titled:

“ADVISORY NOTICE URGENT: MEDICAL DEVICE CORRECTION (bioMérieux FSCA 5761-02) Increased Risk of Power Short with the BIOFIRE^® FILMARRAY^® TORCH System“

*All Fields are Required

Name of Institution*
Job Title*
First Name*
Last Name*
Phone*
Email*
Address*
Street Address Address Line 2 City State / Province / Region ZIP / Postal Code Country
I have read and acknowledged the receipt of the ADVISORY NOTICE URGENT: MEDICAL DEVICE CORRECTION (bioMérieux FSCA 5761-2) Increased Risk of Power Short with the BIOFIRE FILMARRAY TORCH System.*
- Yes
- No
Does your organization have any TORCH instrument bases that have or previously had six (6) or more modules?*
- Yes - By answering yes, you are opting into receiving the power switch replacement. BFDf Technical Support will contact you to organize service.
- No - By answering no, you are acknowledging that you do not have any impacted TORCH instruments and are opting out of receiving the power switch replacement. A replacement service can be requested by contacting BFDf Technical Support at any time.
I have read and acknowledged the receipt of the medical device recall regarding the Torch System power cycling procedures and maintenance.*
- Yes
- No
Electronic Signature*
Date*