VITROS 250 and VITROS 350 Chemistry Systems (2019-04-08)
- Starting date:
- April 8, 2019
- Posting date:
- April 29, 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-69754
Last updated: 2019-04-30
Affected Products
A. VITROS 250 Chemistry System
B. VITROS 350 Chemistry System
Reason
Ortho Clinical Diagnostics determined that VITROS CK Slides do not meet the current on-analyzer stability time of < 1 week when using VITROS 250 or 350 Systems. An internal investigation has shown that quality control results drifted low (i.e., > 2 within lab Standard Deviations (SD) for VITROS Performance Verifiers) when using cartridges stored on the system for less than 7 days.
This issue is related to the humidity control of Slide Supply 2 on VITROS 250/350 Systems.
Ortho has confirmed that CK results generated using VITROS 4600, 5600, XT 7600 and 5,1 FS Systems are NOT affected by this issue.
Affected products
A. VITROS 250 Chemistry System
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
680 1759
Companies
- Manufacturer
-
Ortho-Clinical Diagnostics Inc.
100 Indigo Creek Drive
Rochester
14626
New York
UNITED STATES
B. VITROS 350 Chemistry System
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
680 2153
Companies
- Manufacturer
-
Ortho-Clinical Diagnostics Inc.
100 Indigo Creek Drive
Rochester
14626
New York
UNITED STATES