Product Wiki · Recalls · Health Canada — Medical Devices

IMMULITE System Assays (2016-04-20) — recall 55249

Health Canada — Medical Devices · Canada · 2016-04-29 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
55249
Date of alert
2016-04-29
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: Manufacturer has determined that it takes 24 minutes of incubation prior to process the samples on the IMMULITE/IMMULITE 1000 System for the patient sample and the pretreatment solution to reach full equilibration when using pretreatment solution (LGFA) lot 055 contained in IGF-I Kit lot 411. If patient samples are run before reaching full equilibration an under-recovery of up to -36% may occur. If the sample is left to incubate for more than 24 minutes prior to testing, no under recovery is observed.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/immulite-system-assays-2016-04

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