18

Mar

2015

Cl II VITROS Hand-held Barcode Scanner

0

Company:Ortho-Clinical Diagnostics
Date of Enforcement Report: 3/18/2015
Class lI:

PRODUCT

VITROS Hand-held Barcode Scanner, Catalog Number 6844210, for use with the following VITROS Systems: VITROS 5,1 FS Chemistry System, VITROS 3600 Immunodiagnostics System, VITROS 4600 Chemistry System, VITROS 5600 Integrated System. This product is an accessory for use with VITROS Analyzer Systems.
Recall Number Z-1263-2015

REASON
n combination with the Batch Programming option (only) for programming samples, the hand-held barcode scanner unexpectedly skips sample cup positions within a sample tray. This issue only occurs when using the Batch Programming option; all other sample programming options function as intended..

RECALLING FIRM/MANUFACTURER
Ortho-Clinical Diagnostics, Rochester, NY on 12/29/2014 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
Domestic: 62 units; Foreign: 10 units

DISTRIBUTION
Nationwide and the countries of Canada, Australia and England.

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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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