Ortho-Clinical VITROS 5600 System Recalled for Sample Dispensing Defect
Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated Systems because they may dispense insufficient sample volume without suppressing potentially incorrect results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of incorrect clinical results without reported injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Ortho-Clinical Diagnostics is recalling the VITROS 5600 Integrated System, a device used for in vitro quantitative, semi-quantitative, and qualitative measurement of clinical analytes. The recall is due to a potential defect where the system may dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect result.
The affected units are identified by serial numbers J56000024 through J56003300. The recall covers 1,255 units distributed in the United States and 1,504 units distributed in France, Brazil, Chile, Great Britain, the Philippines, and Spain.
Healthcare facilities and users of the VITROS 5600 Integrated System should contact Ortho-Clinical Diagnostics for instructions on how to proceed with the recall.
The recalled product
- Product
- VITROS 5600 Integrated System-For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, Catalog Number: 6802413
- 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 (1)
- Serial Numbers : J56000024 through J56003300
Distribution
Distributed nationwide across the United States.
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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