Product Wiki · Recalls · Health Canada — Medical Devices

Immage Low Concentration Immunoglobulin M (ILCIgM) (2014-02-10) — recall 51387

Health Canada — Medical Devices · Canada · 2014-03-21 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
51387
Date of alert
2014-03-21
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: Beckman Coulter has confirmed customer complaints regarding image IGMLC reagent lot number M205001. Customers have reported that they have received incorrect results of "greater than 60 mg/L" with an ORHI E65 error message for CSF patient samples which have a true concentration of 1.0 mg/L or less.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/immage-low-concentration-immun

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