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