Product Wiki · Recalls · Health Canada — Medical Devices

RAPIDPOINT 500 CARTRIDGE LACTATE (2015-08-25) — recall 53863

Health Canada — Medical Devices · Canada · 2015-09-08 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
53863
Date of alert
2015-09-08
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: During the manufacturing process, the sodium high calibrator value was incorrectly assigned for the Rapidpoint 500 measurement cartridge (specified serial number range only), causing a negative bias on both QC and patient samples. Cartridges within the specified range, but marked with a green dot on the box and/or cartridge, are not affected.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/rapidpoint-500-cartridge-lacta

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