Reported Mar 18, 2015 · Terminated

VITROS Hand-held Barcode Scanner, Catalog Number 6844210, for use with the following VITROS Systems: VITROS 5,1 FS…

Ortho-Clinical Diagnostics

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Ortho-Clinical Diagnostics · 100 Indigo Creek Dr · Rochester, NY · 14626-5101

Is this the product you have?

  • VITROS Hand-held Barcode Scanner, Catalog Number 6844210, for
  • use with the following VITROS SystemsVITROS 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
Lot codes and dates
  • Lot Numbers

    72 of 72 codes

    • 0914F11968
    • 0914F11969
    • 0914F11970
    • 0914F11971
    • 0914F11972
    • 0914F11973
    • 0914F11974
    • 0914F11975
    • 0914F11976
    • 0914F11977
    • 0914F11978
    • 0914F11979
    • 0914F11980
    • 0914F11981
    • 0914F11982
    • 0914F11983
    • 0914F11984
    • 0914F11985
    • 0914F11986
    • 0914F11987
    • 0914F11988
    • 0914F11989
    • 0914F11990
    • 0914F11997
    • 0914F12007
    • 0914F12016
    • 0914F12017
    • 0914F12020
    • 0914F12022
    • 0914F12028
    • 0914F12033
    • 0914F12037
    • 0914F12039
    • 0914F12040
    • 0914F12041
    • 0914F12046
    • 0914F12048
    • 0914F12049
    • 0914F12050
    • 0914F12053
    • 0914F12054
    • 0914F12055
    • 0914F12056
    • 0914F12057
    • 0914F12058
    • 0914F12059
    • 0914F12060
    • 0914F12061
    • 0914F12062
    • 0914F12063
    • 0914F12064
    • 0914F12065
    • 0914F12066
    • 0914F12067
    • 0914F12081
    • 0914F12082
    • 0914F12083
    • 0914F12084
    • 0914F12085
    • 0914F12086
Amount recalled
Domestic: 62 units; Foreign: 10 units

Where it was sold

  • Nationwide

Why it was recalled

In 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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 27, 2017 · Data as of Sep 19, 6:15 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.