Cl II Roche / Hitachi MODULAR Analyzer Systems

Company:Roche Diagnostics Corporation
Date of Enforcement Report 2/7/2018
Class lI:

PRODUCT

Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/Part Number: 11568248001/11568248692 – Elecsys 2010 analyzer (disk system) and 11804014001/11804014692 – Elecsys 2010 analyzer (rack system) Medical Device Listing number: D053244 – Elecsys 2010 Elecsys analyzer is a fully automated, random access, computer controlled analytical systems for quantitative and qualitative determinations of analytes in body fluids.
Recall Number Z-04992018

REASON
A software malfunction can occur on the cobas e 411 and Elecsys 2010 analyzers in the Sample& Control data file which may lead to a potential data mismatch.

RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corporation, Indianapolis, IN on 7/5/2017. Voluntary firm initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
255 instruments

DISTRIBUTION
Nationwide

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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.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

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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Partners located in the US (CA, FL, MA, MN) and Italy.