CanadaOrtho Connect devices (Ortho‑Connect) by Biomedical Data Solutions Limited with lot/serial number 5060496770066YT and model/catalogue numbers 6904413, 6904415, 6904414, and 6913355 are affected. They were recalled because a potential safety issue was reported where discrepant test results could be incorrectly released to a healthcare environment under very specific conditions; contact the manufacturer if you require additional information.
What's being recalled
Companies: Biomedical Data Solutions Limited, Millenium Court, Burton On Trent, Staffordshire, United Kingdom, DE14 2WH.
How to identify it
Affected products: Ortho-Connect; Lot or serial number: 5060496770066YT; Model or catalogue number: 6904413
Affected products: Ortho-Connect; Lot or serial number: 5060496770066YT; Model or catalogue number: 6904415
Affected products: Ortho-Connect; Lot or serial number: 5060496770066YT; Model or catalogue number: 6904414
Affected products: Ortho-Connect; Lot or serial number: 5060496770066YT; Model or catalogue number: 6913355
The hazard
A potential safety issue was reported of incorrectly releasing discrepant test results to a healthcare environment identified under very specific conditions.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)