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Bioflash System Rinse (2014-01-10)

Starting date:
January 10, 2014
Posting date:
January 24, 2014
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-37641

Recalled Products

  1. Bioflash System Rinse

Reason

When problematic lots of system rinse are used with the Quanta flash MPO reagents (Catalogue number: 701133), the system is not able to successfully complete calibration and the message "average RLU outside calibration range -50% - 50%" is displayed. The Bioflash cannot proceed to perform a MPO test.

Affected products

A. Bioflash System Rinse

Lot or serial number
  • B22718
Model or catalog number
  • 3000-8205
Companies
Manufacturer
Inova Diagnostics Inc.
9900 Old Grove Road
San Diego
92131
California
UNITED STATES