Product Wiki · Recalls · Health Canada — Medical Devices

RAPIDPoint 405, 500 and RAPIDLab 1245 Blood Gas Analyzer (2018-07-24) — recall 58187

Health Canada — Medical Devices · Canada · 2018-08-17 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
58187
Date of alert
2018-08-17
Country / jurisdiction
Canada
Authority classification
Type II
Notice type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Siemens Healthcare Diagnostics has determined that 1 mg/ml and 2 mg/ml of hydroxocobalamin may interfere with Total hemoglobin (tHb) and some of the co-ox fractions that are reported on the RAPIDPoint 405, RAPIDPoint 500, RAPIDLab1245 and RAPIDLab1265 blood gas analyzers. There have not been any reports of injury due to this issue. Siemens is issuing an Urgent Field Safety Notice (UFSN) to inform customers of this potential interfering substance.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/rapidpoint-405-500-and-rapidla

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