VITROS XT7600 Integrated System
Reported: March 13, 2024 Initiated: January 22, 2024 #Z-1222-2024
Product Description
VITROS XT7600 Integrated System
Reason for Recall
Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems which may lead to erroneous test results.
Details
- Recalling Firm
- Ortho-Clinical Diagnostics, Inc.
- Units Affected
- 1,720 units (834 US, 886 OUS)
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, United Kingdom.
- Location
- Rochester, NY
Frequently Asked Questions
What product was recalled? ▼
VITROS XT7600 Integrated System. Recalled by Ortho-Clinical Diagnostics, Inc.. Units affected: 1,720 units (834 US, 886 OUS).
Why was this product recalled? ▼
Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems which may lead to erroneous test results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 13, 2024. Severity: Moderate. Recall number: Z-1222-2024.
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