ORTHO VISION Analyzer & ORTHO VISION Max Analyzer (2019-10-02)
- Starting date:
- October 2, 2019
- Posting date:
- October 25, 2019
- 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-71361
Last updated: 2019-10-25
Affected Products
- ORTHO VISION Analyzer
- ORTHO VISION Max Analyzer
Reason
When two or more samples are loaded for processing with the same Sample ID (duplicate Sample IDs), the analyzer will display Apsw81 error messages ('Sample ID Is Not Unique') and one of the samples may be unexpectedly processed. The error message displayed with the Apsw81 error code states:
- 'The sample barcode ID is not unique ({Sample Barcode*}). The affected sample will not be processed.'
- *The actual duplicate ID is displayed in brackets.
- The unexpected processing creates the potential for results to be associated with the incorrect patient.
Affected products
A. ORTHO VISION Analyzer
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
6904577
Companies
- Manufacturer
-
ORTHO-CLINICAL DIAGNOSTICS INC.
1001 US HWY 202
Raritan
08869
New Jersey
UNITED STATES
B. ORTHO VISION Max Analyzer
Lot or serial number
- 70002012
- 70002013
- 70002021
- 70002022
- 70002027
Model or catalog number
6904576
Companies
- Manufacturer
-
ORTHO-CLINICAL DIAGNOSTICS INC.
1001 US HWY 202
Raritan
08869
New Jersey
UNITED STATES