VITROS XT 7600 Integrated System, Catalog No. 6844461
Reported: March 13, 2024 Initiated: January 26, 2024 #Z-1228-2024
Product Description
VITROS XT 7600 Integrated System, Catalog No. 6844461
Reason for Recall
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.
Details
- Recalling Firm
- Ortho-Clinical Diagnostics, Inc.
- Units Affected
- 44 US; 35 OUS
- Distribution
- Worldwide - US Nationwide distribution in the states of AZ, CA, CT, FL, IA, ID, IL, IN, KY, LA, MO, NE, NY, OH, OR, SC, SD, TX, WA, WI, WV and the countries of Australia, Brazil, Canada, China, Colombia, India, Mexico, Singapore, United Kingdom, Italy, Spain, Russia, France, and Belgium.
- 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: 44 US; 35 OUS.
Why was this product recalled? ▼
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This 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-1228-2024.
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