Vitros 5 recall: Software Issue
VITROS 5,1 FS System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical…
Why was Vitros 5 recalled?
software automatically switches the lot when a vancomycin (VANC) or valproic acid (VALP) reagent is depleted or the operator manually changes the lot in use causing lack of verification of proper quality assessment.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Version 2.6.1 & Below
- 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…
- Recalling firm
- Ortho-Clinical Diagnostics
- Quantity
- 2044
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of Australia, New Zealand, Brazil, Canada, Chile, Argentina, Paraquay, Ecuador, Colombia, India, Japan, Mexico, Panama, Singapore, Venezuela, UK, Northern Europe, France, Germany, Italy, Spain and Portugal.
- Recall date
- August 1, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)