Ortho-Clinical Diagnostics Recalls VITROS 5,1 FS System Software
Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS System Software versions 2.6.1 and below because the software may fail to verify quality assessments 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 of quality assessment for clinical analytes, which poses a risk of harm through inaccurate results, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Ortho-Clinical Diagnostics is recalling 2,044 units of VITROS 5,1 FS System Software, versions 2.6.1 and below. The software is used for the in-vitro quantitative, semi-quantitative, and qualitative measurement of various analytes of clinical interest.
The recall is due to a defect where 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 behavior 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 should contact Ortho-Clinical Diagnostics for further instructions.
The recalled product
- Product
- VITROS 5,1 FS 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
- 2,044
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 2.6.1 & 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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