QUANTA Flash DFS70 Controls (2018-11-10)

Starting date:

November 10, 2018

Posting date:

March 15, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-69308

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  Reason
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  Affected products

Affected Products

QUANTA Flash DFS70 Controls

Reason

Upon investigation into complaints from customers, Inova Diagnostics has confirmed that the positive control value on lots 171589, 181676 and 181799 of QUANTA Flash DFS70 Controls fall below the acceptable range. When control values fall outside of the acceptable range, the run is considered invalid. Results from an invalid run cannot be reported and the run needs to be repeated.

Affected products