FYI -TGA: D MAX SARS-COV-2 REAGENT 445003 Urgent medical device defect correction

[Anonymous]

D MAX SARS-COV-2 REAGENT 445003
Urgent medical device defect correction

BD have received reports of false positive results when using the BD SARS-CoV-2 Reagents with the BD MAX System predominantly on the N2 target.

The low N2 threshold of 50 Relative Fluorescence Units (RFU) was not adequate. BD has revised and has updated the threshold for the N2 target in the instructions for use (IFU) from 50 RFU to 80 RFU.
See TGA recall notice: https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?kRC-2020-RN-00632-1

Regards,
Kelly
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I acknowledge the traditional owners of the land on which we work & live, & respect their ongoing custodianship of the land. I pay respect to Alpine Aboriginal people, & Elders past & present.

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Kelly Barton
Infection Prevention & Control Officer
RN BHSc (Nursing). Grad Cert (Infection Control)(Advanced Acute Care). Nurse Immuniser. Cert IV T&A
P Reduce, re-use, recycle. Please consider the environment before printing this e-mail.

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