Oct

2014

ClII ViroSeq HIV-1 Genotyping System v2.0

Company: Celera Corporation.
Date of Enforcement Report:10/1/2014
Class lII:

PRODUCT

ViroSeq HIV-1 Genotyping System v2.0, consisting of ViroSeq HIV-1 Genotyping System v2.0 reagent kit and Genotyping Software v3.0. Also contains ViroSeq HIV-1 Genotyping Software Manual and System v2.0 (3130) Operators Manual
Recall Number B-0993-14

REASON
ViroSeq HIV-1 Genotyping System v2.0, not meeting labeling claim, was distributed..

RECALLING FIRM/MANUFACTURER
Celera Corporation, Alameda, CA on 6/18/2014 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
1 unit

DISTRIBUTION
US, Taiwan, Singapore, and Hong Kong.

___________________________________

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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ClII ViroSeq HIV-1 Genotyping System v2.0

Amy Sellers

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