Ortho-Clinical Diagnostics Recalls VITROS 4600 Chemistry System Software
Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry System Software due to a defect that prevents proper quality assessment 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. The hazard involves a lack of verification for quality assessment in a medical device, which poses a risk of harm to patients through potential diagnostic errors, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Ortho-Clinical Diagnostics is recalling 77 units of VITROS 4600 Chemistry System Software, Version 2.0 and below. The software is used for in-vitro quantitative, semi-quantitative, and qualitative measurement of various analytes of clinical interest.
The recall is due to a software defect where the system 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 in the United States, 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 of the affected software should contact Ortho-Clinical Diagnostics for further instructions on remediation.
The recalled product
- Product
- VITROS 4600 Chemistry 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
- 77
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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