Ortho-Clinical Diagnostics Recalls VITROS 5600 Integrated System Software
Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated System Software due to a defect that prevents proper quality verification when reagent lots are switched.
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-harm product (medical device software) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Ortho-Clinical Diagnostics is recalling 1,387 units of VITROS 5600 Integrated System Software, specifically Version 2.0 and below. The software is used for in-vitro quantitative, semi-quantitative, and qualitative measurement of various clinical analytes.
The recall is being issued because the software automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent is depleted, or when an operator manually changes the lot in use. This action causes a lack of verification of proper quality assessment.
The affected software was distributed worldwide, including the United States (nationwide), Australia, New Zealand, Brazil, Canada, Chile, Argentina, Paraguay, Ecuador, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, the UK, Northern Europe, France, Germany, Italy, Spain, and Portugal. Users should contact Ortho-Clinical Diagnostics for further instructions regarding the recall.
The recalled product
- Product
- VITROS 5600 Integrated System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest.
- Manufacturer
- Ortho-Clinical Diagnostics
- Affected units
- 1,387
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)
- Version 2.0 & Below
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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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