Jun

2004

Roche Diagnostics Corp Class I

Company: Roche Diagnostics Corp
Date of Enforcement Report: 6/23/04
Class: I

PRODUCT
COBAS Gui software interface between the Cobas AMPLICOR instrument and the Tecan clinical workstation (Tecan Genesis 150/8 front end COBAS), Roche catalog number 04498984001. Recall # Z-1021-04.

REASON
The Roche COBAS interface driver for the Tecan software may assign sample results to the wrong patient.

CODE
All units (serial numbers 6178, 7629, 7698, 7744, 7753, 7754, 7755 and 7768.

RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corp, Indianapolis, IN, by letter dated May 5, 2004 and press release on May 7, 2004. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
8 units.

DISTRIBUTION
CA, CT, IL, MA, PA, TX and WI.

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 I

Amy Sellers

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