Product Wiki · Recalls · Health Canada — Medical Devices

Immage Immunochemistry Systems Properdin Factor B and Vigil Protein… — recall 50106

Health Canada — Medical Devices · Canada · 2013-10-31 · Type III

As described by Health Canada — Medical Devices: Immage Immunochemistry Systems Properdin Factor B and Vigil Protein Control (2013-09-18)

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Agency
Health Canada — Medical Devices
Recall identifier
50106
Date of alert
2013-10-31
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 differences in recovery of PFB in Vigil protein control using PFB reagent lots M206298, M301364, M302049 compared to values obtained using previous PFB reagent lots. These control differences are due to a change in the pool of antiserum material that is used in the manufacture of the PFB reagent. The control range tables included in Vigil protein control lots M210051, M210052 and M210053 do not reflect PFB values obtained with PFB reagent lots M206298, M301364 and M302049.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/immage-immunochemistry-systems

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