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Nova Gel SS-A/SS-B "T" (2013-09-06)
- Starting date:
- September 6, 2013
- Posting date:
- September 27, 2013
- 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-35921
Recalled products
A. Nova Gel SS-A/SS-B "T"
Reason
As a result of the investigation of a complaint regarding the product mentioned above, the manufacturer, inova diagnostics, has confirmed that there is no visible precipitin line that develops between the SS-B positive control well and the SS-B antigen well on the Nova gel plate within the expected 24 to 48 hour timeframe. This would result in an invalid test result and therefore, no results would be reported.
Affected products
A. Nova Gel SS-A/SS-B "T"
Lot or serial number
- 003048
Model or catalog number
- 708455
Companies
- Manufacturer
-
Inova Diagnostics Inc.
9900 Old Grove Road
San Diego
92131
California
UNITED STATES