Nov

2013

Cl II Ortho Verseia Pipetter (VERSEIA)

Company: Ortho Clinical Diagnostics Inc
Date of Enforcement Report: 11/6/2013
Class lI:

PRODUCT

Ortho Verseia Pipetter (VERSEIA) Recall Number B-2518-13

REASON
ORTHO VERSEIA Pipetter software, with a defect or glitch that in certain circumstances during plate processing, has the potential for false negative results.

RECALLING FIRM/MANUFACTURER
Ortho Clinical Diagnostics Inc, Raritan, NJ on 8/21/2013. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
4

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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Cl II Ortho Verseia Pipetter (VERSEIA)

Amy Sellers

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