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Health Canada Medical devices

Freelite Human Lambda Free Kit (for use on the SPAPLUS)

Issued November 12, 2021
Issue
Following an investigation of customer complaints, an increase in curve activity and decrease in top point separation between calibrator (CAL) points 5 and 6 was observed for IK018.S lot 472776 (lK018.L.S lot 435251 shares the same components). Cal. 5 OD values may occasionally exceed Cal.6 Values, which may lead to imprecision within this region of the curve. Therefore, TBS will initiate the correction by way of issuing an UFSN to the affected customers. Recall date: 2021-10-14
Hazard description
Inaccurate test or measurement results
What to do
Immediately stop using the product and contact manufacturer.
Product
Product name
Freelite Human Lambda Free Kit (for use on the SPAPLUS)
Reference
ID
RA-63586