FDAFDA · Food and drugs·Recall number Z-1220-2024
VITROS 3600 Immunodiagnostic System (New and Refurbished)
Published March 13, 2024 · Recall initiated: January 22, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Distributor
- 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.
- Lot
- Code Information: UDI/DI: (New) 10758750002979, (Refurbished) 10758750007103; Serial Numbers: J36001164 through J36001692 (inclusive).
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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