Cl Il Roche/Hitachi Modular Analytics System

Company: Roche Diagnostics Corp/Hitachi Ltd
Date of Enforcement Report 8/20/2008
Class:ll

PRODUCT
a) Roche/Hitachi Modular Analytics System, Modular D2400 Module GMMI clinical
chemistry analyzer; Catalog number 04998618001. Intended for qualitative and
quantitative in vitro determinations using a wide variety of tests; Z-0866-2008;
b) Roche/Hitachi Modular Analytics System, Modular P800 Module GMMI clinical
chemistry analyzer; Catalog number 04998669001. Intended for qualitative and
quantitative in vitro determinations using a wide variety of tests; Z-0867-2008;
c) Roche/Hitachi Modular Analytics System, Modular E Module GMMI immunoassay
analyzer; Catalog numbers 04998642001 and 03617505001. Intended for qualitative
and quantitative in vitro determinations using a wide variety of tests; Recall # Z-0868-
2008;
d) Roche/Hitachi Modular Analytics System, Modular D Module GMMI clinical
chemistry analyzer; Catalog number 03284522001. Intended for qualitative and
quantitative in vitro determinations using a wide variety of tests; Recall # Z-0869-
2008;
e) Roche/Hitachi Modular Analytics System Modular P Module GMMI immunoassay
analyzer; Catalog number 03284549001. Intended for qualitative and quantitative in
vitro determinations using a wide variety of tests; Recall # Z-0870-2008

REASON
Possible mismatch between patient and result.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letter dated March 21, 2008.
Manufacturer: Division, Hitachi Ltd., Hitachinaka-Ibaraki, Japan. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
11 units

DISTRIBUTION
Nationwide

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.