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Health Canada Medical devices

CALiaGold PierceTube

Issued July 4, 2024
Issue
Following a customer complaint, Sentinel detected a defect in three (3) lots of the collection tube CALiaGold PierceTube, ref. 1151300: lot 31390, 40037, 40045. The defect is an inner plastic crack that connects the two chambers of the collection tube, causing a reduction of the buffer volume needed for the measurement. It cannot be excluded that a significant volume decrease may lead to the impossibility to perform the test. The root cause of the plastic crack is still under investigation. Recall Start Date: June 13, 2024
Hazard description
Performance
Product
Product name
CALiaGold PierceTube
Reference
ID
RA-75788