Ortho-Clinical Diagnostics Recalls VITROS 5600 Integrated Systems
Ortho-Clinical Diagnostics is recalling refurbished VITROS 5600 Integrated Systems because they may dispense insufficient sample volumes without suppressing potentially incorrect results.
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 3/5 (High).
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 harm (incorrect clinical results) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Ortho-Clinical Diagnostics is recalling refurbished VITROS 5600 Integrated Systems (Catalog Number: 6802915). These devices are used for the in vitro quantitative, semi-quantitative, and qualitative measurement of various analytes of clinical interest.
The recall is due to a potential for the system to dispense an insufficient sample volume onto a MicroSlide without suppressing the potentially incorrect result. This defect could lead to inaccurate clinical measurements.
The recall affects 66 units in the United States and 76 units in foreign countries, including France, Brazil, Chile, Great Britain, the Philippines, and Spain. Specific serial numbers for affected units are listed in the agency's recall record. Users of these devices should contact Ortho-Clinical Diagnostics for further instructions on how to address the issue.
The recalled product
- Product
- VITROS 5600 Integrated System- (Refurbished). For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, Catalog Number: 6802915
- Manufacturer
- Ortho-Clinical Diagnostics
- Hazard
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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Similar recalls
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