VITROS® Systems
Brand(s)
Last updated
Summary
Product
VITROS® Systems
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalog number |
|---|---|---|
| VITROS® 3600 Immunodiagnostic System-Instrument | Software Version 3.8.0 and 3.8 | 680 2914 680 2783 |
| VITROS® XT 7600 Integrated System | Software Version 3.8.0 and 3.8 | 684 4461 |
| VITROS® 4600 Chemistry System - Hardware | Software Version 3.8.0 and 3.8 | 680 2445 690 0440 |
| VITROS® 4600 Chemistry System - Refurbished Hardware | Software Version 3.8.0 and 3.8 | 690 0440 |
| VITROS® 5600 Integrated System | Software Version 3.8.0 and 3.8 | 680 2413 680 2915 |
| VITROS® XT 3400 Chemistry System | Software Version 3.8.0 and 3.8 | 684 4458 |
Issue
Issue #1 - QC baseline statistics are not updating as expected. This only affects VITROS® Systems running VITROS® system software version 3.8.1.
Issue #2 - Configurable westgard rules are not being applied as expected. This affects VITROS® Systems running VITROS® System software versions 3.8.0 and 3.8.1.
Recall start date: January 31, 2024
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies
Ortho-Clinical Diagnostics Inc.
100 Indigo Creek Drive, Rochester, New York, United States, 14626
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75059
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