VITROS XT 7600 Integrated System, Catalog No. 6844461
Reported: March 13, 2024 Initiated: January 26, 2024 #Z-1233-2024
Product Description
VITROS XT 7600 Integrated System, Catalog No. 6844461
Reason for Recall
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which may cause erroneous patient results to be reported.
Details
- Recalling Firm
- Ortho-Clinical Diagnostics, Inc.
- Units Affected
- 142 US; 78 OUS
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom.
- Location
- Rochester, NY
Frequently Asked Questions
What product was recalled? ▼
VITROS XT 7600 Integrated System, Catalog No. 6844461. Recalled by Ortho-Clinical Diagnostics, Inc.. Units affected: 142 US; 78 OUS.
Why was this product recalled? ▼
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which may cause erroneous patient results to be reported.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 13, 2024. Severity: Moderate. Recall number: Z-1233-2024.
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