Product Wiki · Recalls · Health Canada — Medical Devices

Advia Centaur, Centaur CP, and Centaur XP Systems — recall 51219

Health Canada — Medical Devices · Canada · 2014-04-04 · Type III

As described by Health Canada — Medical Devices: Advia Centaur, Centaur CP, and Centaur XP Systems - Procaclitonin Assay (PCT) (2014-02-21)

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Agency
Health Canada — Medical Devices
Recall identifier
51219
Date of alert
2014-04-04
Country / jurisdiction
Canada
Authority classification
Type III
Notice type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Siemens Healthcare Diagnostics received customer feedback regarding the clinical utility of Advia Centaur Brahms Procalcitonin (PCT) quality control level 1. Quality control level 1 currently has a range of plus or minus 50% of the target. Siemens internal investigation confirmed that this range was incorrectly set. Siemens has revised the range of Advia Centaur Brahms Procalcitonin (PCT) quality control level 1 to plus or minus 30% of the target. A review of test data confirmed the assay is capable of achieving a narrower range of plus or minus 30% of the target.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/advia-centaur-centaur-cp-and-c

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