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Simplexa Direct Detection PCR Assays (2016-02-10)
- Starting date:
- February 10, 2016
- Posting date:
- March 10, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-57484
Affected products
- Simplexa Flu A/B & RSV Direct
- Simplexa HSA 1 & 2 Direct
- Simplexa Group A Strep Direct
Reason
Customer correction notice. Do not reuse Direct Amplification Disc (DAD) within test kit. The reuse may result in false negative, false positive or error codes (500, 505 or insufficient specimen volume) at this time.
Affected products
-
Simplexa Flu A/B & RSV Direct
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
- MOL2650
Companies
- Manufacturer
-
Focus Diagnostics Inc.
11331 Valley View Street
Cypress
90630
California
UNITED STATES
B. Simplexa HSA 1 & 2 Direct
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
MOL2150
Companies
- Manufacturer
-
Focus Diagnostics Inc.
11331 Valley View Street
Cypress
90630
California
UNITED STATES
C. Simplexa Group A Strep Direct
Lot or serial number
More than 10 numbers, contact manufacturer
Model or catalog number
MOL2850
Companies
- Manufacturer
-
Focus Diagnostics Inc.
11331 Valley View Street
Cypress
90630
California
UNITED STATES