Cl ll VITROS ECi Immunodiagnostic System

Company:Ortho-Clinical Diagnostics
Date of Enforcement Report 5/2/12
Class ll:

PRODUCT
1) VITROS? ECi Immunodiagnostic System, Catalog No. 8633893 — COMMON/USUAL NAME: VITROS? ECi System. All systems that has Software Version 3.8 or below installed and on which the VITROS? Total B-hCG II Reagent Pack (human chorionic gonadotropin) is processed. Product Usage: For in vitro diagnostic use only. To perform random access, batch and STAT immunodiagnostic assays on human fluid specimens. Recall # Z-0923-2012

2) VITROS? ECiQ Immunodiagnostic System, Catalog No. 1922814 — COMMON/USUAL NAME: VITROS? ECiQ System. All systems that has Software Version 3.8 or below installed and on which the VITROS? Total B-hCG II Reagent Pack (human chorionic gonadotropin) is processed. Product Usage: For in vitro diagnostic use only. To perform random access, batch and STAT immunodiagnostic assays on human fluid specimens. Recall # Z-0924-2012

REASON
Software defect; Ortho Clinical Diagnostics received complaints of observed results from diluted samples that were reported as <2.39 mIU/mL (IU/L) instead of the correct No Result, which is accompanied by an Invalid Dilution (ID) code.

RECALLING FIRM/MANUFACTURER
Ortho-Clinical Diagnostics, Rochester, NY, by letters on August 24, 2011. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
ECi: 1921 (Domestic 808, Foreign 1113); ECiQ: 2200 (Domestic 906, Foreign 1294)

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
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.