01
Aug
2012

1 FS System Software, Cl ll VITROS 5

0

Company:Ortho-Clinical Diagnostics
Date of Enforcement Report 8/112
Class ll:

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. Z-2066-2012

REASON
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.

RECALLING FIRM/MANUFACTURER
Ortho-Clinical Diagnostics, Rochester, NY on 5/21/2012. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
2044 units

DISTRIBUTION
Nationwide and Internationally

___________________________________

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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