29

Mar

2012

Cl ll Elecsys 2010 Analyzer Software

0

Company:Roche Diagnostics Operations, Inc.
Date of Enforcement Report 3/28/12
Class ll:

PRODUCT
LElecsys 2010 Analyzer Software version 06-07 The Elecsys 2010 analyzer is intended for the in vitro quantitative and qualitative analysis of analytes in body fluids. a) Elecsys 2010 Analyzer Rack; b) Elecsys 2010 Analyzer Disk; c) Software version 06-07. Recall # Z-1218-2012

REASON
Elecsys 2010 customers have reported getting no value and flag 48 results below expected value range after performing automatic dilution for a sample that previously recovered above the measuring range. Incorrect but believable results may occur for the CEA, Rubella IgG or SHBG assays. The other affected assays will generate either no value or a negative result, both of which are not believable since the sample was diluted due to a result that was initially too high.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Operations, Inc., Indianapolis, IN, by letter dated January 31, 2012.
Manufacturer: Hitachi Ltd., Hitachinaka-Ibaraki, Japan. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
13 ACCOUNTS in USA

DISTRIBUTION
Nationwide and Internationally

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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