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