Z-1221-2024 Class II Ongoing
FDA device recall Z-1221-2024 was initiated by Ortho-Clinical Diagnostics, Inc. on Jan 22, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 1460 units (506 US, 954 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- Mar 13, 2024
- Initiation Date
- Jan 22, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1460 units (506 US, 954 OUS)
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.
Distribution Pattern
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.
Code Information
UDI/DI: (New) 10758750002740, (Refurbished) 10758750007110; Serial Numbers: J56000280, J56000330, J56000415, J56000631, J56000634, J56000721, J56000839, J56000871, J56001088, J56001209, J56001228, J56001265, J56001305, J56001355, J56001834, J56001855, J56001941, J56001998, J56002111, J56002239, J56002476, J56002492, J56002531, J56002561, J56002649, J56002655, J56002658, J56002691 and J36001164 through J36001692 (inclusive).
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1221-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026