VITROS® Systems
Brand(s)
Summary
Contact the manufacturer if you require additional information.
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 |
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 |
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 |
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
Ortho-Clinical Diagnostics Inc.
100 Indigo Creek Drive, Rochester, New York, United States, 14626
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