VITROS 5600 Integrated System (New and Refurbished)
Reported: March 13, 2024 Initiated: January 22, 2024 #Z-1221-2024
Product Description
VITROS 5600 Integrated System (New and Refurbished)
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
- 1460 units (506 US, 954 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 5600 Integrated System (New and Refurbished). Recalled by Ortho-Clinical Diagnostics, Inc.. Units affected: 1460 units (506 US, 954 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-1221-2024.
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