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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Need Your Input!

We have been researching where and when to hold our next 3-day 62304/FDA training course and we want your feedback!
1) Does the location in the US for a public course matter to you … for example, west coast (e.g., San Francisco area) vs. east coast (e.g., Boston)?
2) What locations do you prefer?
3) Would you prefer just the 3-day FDA/62034 course or to have the option of a full week 3-day course followed by cybersecurity 1-day, and a usability 1-day?
4) What other countries would you want to see our course offered publicly?
5) What are best two months of the year for the course?  What are the least favored (not workable) months?
Please respond by email to

office@softwarecpr.com by Sep 25, 2019 if possible!

Corporate Office

15148 Springview St
Tampa, FL 33624
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+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.