This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
OPTI Analyzers (2015-04-20)
- Starting date:
- April 20, 2015
- Posting date:
- May 26, 2015
- 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-53439
Recalled Products
- OPTI R Analyzer
- OPTI CCA Analyzer
- OPTI CCA-TS2 Analyzer
- OPTI CCA-TS Analyzer
Reason
OPTI medical investigated a report from the field where an OPTI CCA-TS2 was found to measure THB high in whole blood. Internal investigation has reproduced this finding, showing a positive bias in THB results in whole blood when saturated oxygen (SO2) is low. This issue was found on all OPTI blood gas analyzers manufactured after July 2009.
Affected products
A. OPTI R Analyzer
Lot or serial number
1334 and higher
Model or catalog number
GD7031
Companies
- Manufacturer
-
OPTI Medical Systems Inc.
235 Hembree Park Drive
Rosewell
30076
UNITED STATES
B. OPTI CCA Analyzer
Lot or serial number
8056 and higher
Model or catalog number
GD7045
Companies
- Manufacturer
-
OPTI Medical Systems Inc.
235 Hembree Park Drive
Rosewell
30076
UNITED STATES
C. OPTI CCA-TS2 Analyzer
Lot or serial number
All lots.
Model or catalog number
GD7046
Companies
- Manufacturer
-
OPTI Medical Systems Inc.
235 Hembree Park Drive
Rosewell
30076
UNITED STATES
D. OPTI CCA-TS Analyzer
Lot or serial number
2700 and higher
Model or catalog number
GD7013
Companies
- Manufacturer
-
OPTI Medical Systems Inc.
235 Hembree Park Drive
Rosewell
30076
UNITED STATES