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Ortho-Clinical Diagnostics recalls VITROS Hand-held Barcode Scanner, Catalog Number 6844210, for use with the following VITROS Systems: VITROS 5,1 FS Chemi
Recalled March 18, 2015 · FDA recall Z-1263-2015 · Ortho-Clinical Diagnostics
Hazard
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. · FDA Class II
Units
Domestic: 62 units; Foreign: 10 units
Sold at
Worldwide Distribution-US (nationwide) and the countries of Canada, Australia and England.
Description
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.
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.
Manufacturer(s)
Ortho-Clinical Diagnostics
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →