Ortho-Clinical Diagnostics Recalls VITROS TIBC Calibrator Kits Due to Performance Shift
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 4 and Fe Slides because TIBC results may be approximately 80 ug/dL lower than expected.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a performance shift in test results without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Ortho-Clinical Diagnostics, Inc. is recalling VITROS Chemistry Products Calibrator Kit 4 (Product Code 1204668) and VITROS Chemistry Products Fe Slides (Product Nos. 7541, 1924547, 1515808, and 6802198). The recall involves 7,546 kits in the US and 15,280 kits outside the US, distributed worldwide including in the United States, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, and the United Kingdom.
The recall is due to a potential performance shift in Total Iron-Binding Capacity (TIBC) results. The shift begins with the newest Generation (GEN) of VITROS Fe Slides (GEN 26). For GEN 26 and above, TIBC patient values may be approximately 80 ug/dL lower across the measuring range compared to other available generations (GENs 22-25).
Healthcare facilities and laboratories using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems or VITROS 5600/XT 7600 Integrated Systems should stop using the affected products and contact Ortho-Clinical Diagnostics for further instructions.
The recalled product
- Product
- VITROS Chemistry Products Calibrator Kit 4-(Calibrator values for TIBC only). Used to calibrate VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems Product Code: 1204668 Impacted Products: A. VITROS Chemistry Products TIBC Kit
- Manufacturer
- Ortho-Clinical Diagnostics, Inc.
- Hazard
Distribution
Distributed nationwide across the United States.
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