Ortho VITROS 5600 Integrated System Recalled for Calibration Anomaly
Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems due to a software anomaly that may cause unexpected assay calibration when using specific calibrator kits.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a software anomaly leading to potential calibration errors, which fits the criteria for a moderate severity recall involving a risk of harm without reported adverse events.
Plain-English summary
Ortho-Clinical Diagnostics (OCD) is recalling the VITROS 5600 Integrated System, System Product Code 6802413. The recall affects units running Software Version 3.0 and below with serial numbers ranging from J56000110 to J56001995. The affected systems are used for in vitro quantitative, semi-quantitative, and qualitative measurement of various clinical analytes.
The recall was initiated after OCD identified an anomaly in the software. Internal testing confirmed that an unexpected assay calibration may occur if assay targets are unassigned (hidden) while using calibrator barcode labels supplied with VITROS Chemistry Products Calibrator Kits 1, 2, 3, 4, 6, or 9. This issue was identified on VITROS 4600 Chemistry Systems and VITROS Integrated Systems.
The affected units were distributed worldwide, including the United States (nationwide, including Puerto Rico) and countries such as Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela. A total of 843 units were distributed in the USA and 945 units were distributed in foreign markets. Users should contact Ortho-Clinical Diagnostics for instructions on how to address the software anomaly.
The recalled product
- Product
- VITROS 5600 Integrated System, System Product Code 6802413. For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents…
- Manufacturer
- Ortho-Clinical Diagnostics
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Software Version 3.0 and below
- Serial Numbers J56000110 - J56001995 (serial numbers are sequential
- J Numbers are analogous to serial numbers)
Distribution
Part of a larger recall action
This product is one of 2 recalled by Ortho-Clinical Diagnostics under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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