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Simplexa Flu A/B and RSV Direct Assay (2014-01-10)

Report a Concern
Starting date:
January 10, 2014
Posting date:
February 11, 2014
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-37913

Recalled Products

  1. Simplexa Flu A/B and RSV Direct Assay

Reason

Simplexa FLU A/B and RSV direct assay has potential to give false postive RSV result.

Affected products

A. Simplexa Flu A/B and RSV Direct Assay

Lot or serial number
  • 24493
  • 24495
  • 24535
  • 24536
Model or catalog number
  • MOL2650
Companies
Manufacturer
Focus Diagnostics Inc.
11331 Valley View Street
Cypress
90630
California
UNITED STATES