Oct

2003

Roche Diagnostics Corp Class II

Company: Roche Diagnostics Corp
Date of Enforcement Report: 10/22/03
Class: II

PRODUCT
Roche/Hitachi Modular Analytics P clinical chemistry analyzer; Modular P. Catalog number 766-8156. Recall # Z-0012-04.

REASON
Incorrect results, without a data flag, reported if one of the other reagent containers becomes depleted before the RI reagent is depleted.

CODE
All units with current software versions (v 06-06 and 07-01).

RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corp., Indianapolis, IN, by letter on or about May 12, 2003. Firm initiated recall is complete.

VOLUME OF PRODUCT IN COMMERCE
478.

DISTRIBUTION
Nationwide.

About the author

Amy Sellers

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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Roche Diagnostics Corp Class II

Amy Sellers

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