Recall Z-1114-2013 — CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner. Used with the CoagCHEK XS Pro Meters to quantitatively determines prothrombin time ("PT").
U.S. FDA — Device Enforcement · United States · 2013-03-06 · Class II
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Reported risk: Roche investigation into complaints found Accu-Chek Inform II and CoaguChek XS Pro System barcode reading meters had the potential of intermittent erroneous decoding of patient identification if barcodes being read fail to meet size and/or quality standards. Errors have been confirmed with the EAN 13 barcodes which should not be used for patient or operator identification.
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