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

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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Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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