Product Wiki · Recalls · Health Canada — Medical Devices

ADVIA Centaur and Centaur CP Systems (2015-01-27) — recall 52791

Health Canada — Medical Devices · Canada · 2015-02-06 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
52791
Date of alert
2015-02-06
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: There is a high bias on results greater than 30 ng/ml (95.4 nmol/l) when compared to the master curve when using select ADVIA centaur progesterone kit lots. The high bias may cause neat serum samples with results greater than 60 ng/ml (190.8 nmol/l) to recover within the assay range upon dilution (dilution factor applied). Samples with values below 30 ng/ml (95.4 nmol/l) do not demonstrate this bias.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/advia-centaur-and-centaur-cp-s

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