Recall – Cl ll VITROS 5600 Integrated System Software

Company:Ortho-Clinical Diagnostics.
Date of Enforcement Report 6/6/12
Class ll:

PRODUCT
VITROS 5600 Integrated System Software Version 1.6 & Below Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents. Product code: 6802413. Recall # Z-1699-2012

REASON
Recall because of an anomaly that may inadvertently add a surfactant to a CurveTip position.

RECALLING FIRM/MANUFACTURER
Ortho-Clinical Diagnostics, Rochester, NY, by letter dated April 26, 2012. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1,357 units

DISTRIBUTION
Nationwide and Internationally

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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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