Product Wiki · Recalls · Health Canada — Medical Devices

ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEMS AND STRIPS… — recall 54811

Health Canada — Medical Devices · Canada · 2016-02-01 · Type II

As described by Health Canada — Medical Devices: ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEMS AND STRIPS (2016-01-11)

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Agency
Health Canada — Medical Devices
Recall identifier
54811
Date of alert
2016-02-01
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: IRIS international has become aware of loose or missing analyte pads being found in several locations (strip vial, strip provider module, strip conveyor system or waste container) that are undetectable by the iChem VELOCITY system. If affected strips are used to assay patient samples, the issue has the potential to cause erroneous pH results and false negative results for the following tests: nitrite, glucose, blood, bilirubin, urobilinogen, protein, leukocyte esterase, ketones, and ascorbic acid.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/ichem-velocity-automated-urine

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