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.
FDA Recall Z-1263-2015 · Posted 2015-03-11
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Recalling FirmOrtho-Clinical Diagnostics
Recall StatusTerminated
Product CodeN/A
Date Initiated2014-12-29
Date Terminated2017-03-27
Product QuantityDomestic: 62 units; Foreign: 10 units
Reason for Recall
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.
Firm Action
On 12/29/2014, Customer letter (Ref. CL2014-315) was sent via FedEx overnight courier or ORTHO PLUS e-Communications and/or US Postal Service Priority Mail (for PO Boxes only) to US consignees (OCD Direct, Drop-Ship and US Federal Government) to inform them of the issue and provided with instructions for reconfiguring their Barcode Scanners.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution-US (nationwide) and the countries of Canada, Australia and England.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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