FDA Enforcement
Class II
Ongoing
VITROS 3600 Immunodiagnostic System (New and Refurbished)
Recall: Z-1220-2024
·
Reported March 13, 2024
Enforcement
- Recall Number
- Z-1220-2024
- Event ID
- 93892
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Ortho-Clinical Diagnostics, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 13, 2024
- Initiation Date
- January 22, 2024
- Classification Date
- March 1, 2024
- Address
- 100 Indigo Creek Dr, Rochester, NY, 14626-5101, United States
Description
VITROS 3600 Immunodiagnostic System (New and Refurbished)
Reason
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.
Code Info
Code Information: UDI/DI: (New) 10758750002979, (Refurbished) 10758750007103; Serial Numbers: J36001164 through J36001692 (inclusive).
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.
Quantity
489 units (46 US, 443 OUS)