Health product recall

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

Last updated

Summary

Product
Freelite Human Lambda Free Kit (for use on the SPAPLUS)
Issue
Medical devices - Inaccurate test or measurement results
What to do
Immediately stop using the product and contact manufacturer. 

Affected products

Affected Products Lot or serial number Model or catalog number
FREELITE HUMAN LAMBDA FREE KIT,USE ON THE SPA PLUS Lot: 435251 Lot: 472776 LK 018.S LK018.L.S

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

What you should do

Immediately stop using the product and contact manufacturer. 

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices
Companies

THE BINDING SITE GROUP LIMITED

8 CALTHORPE ROAD, EDGBASTON, B15 1QT

 

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63586