Ortho Connect Medical Device Recall for Incorrect Test Results
Summary
Health Canada has issued a Type II recall for the Ortho Connect medical device manufactured by Biomedical Data Solutions Limited due to the potential for incorrect test results. The recall affects specific lot and model numbers, with a recall date of February 19, 2026.
What changed
Health Canada has initiated a Type II recall for the Ortho Connect medical device, manufactured by Biomedical Data Solutions Limited. The recall is due to a potential safety issue where the device may incorrectly release discrepant test results under specific conditions. Affected products include specific lot numbers (5060496770066YT) and model numbers (6904413, 6904414, 6904415, 6913355).
Healthcare providers and the general public are advised to contact the manufacturer for additional information. This recall highlights the critical need for medical device manufacturers to ensure the accuracy and reliability of their diagnostic equipment. Failure to address such performance issues can lead to misdiagnosis and patient harm, necessitating prompt corrective actions by the manufacturer and vigilance from healthcare facilities.
What to do next
- Contact the manufacturer for additional information regarding the Ortho Connect medical device recall.
- Review affected product lot and model numbers to determine if specific devices are impacted.
- Implement any manufacturer-provided corrective actions or withdrawal procedures.
Archived snapshot
Mar 20, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Health product recall
Ortho Connect
Brand(s)
Biomedical Data Solutions Limited
Last updated
2026-03-19
Summary
Product Ortho Connect Issue Medical devices - Performance What to do Contact the manufacturer if you require additional information.
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Ortho-Connect | 5060496770066YT | 6904413 |
| Ortho-Connect | 5060496770066YT | 6904415 |
| Ortho-Connect | 5060496770066YT | 6904414 |
| Ortho-Connect | 5060496770066YT | 6913355 |
Issue
A potential safety issue was reported of incorrectly releasing discrepant test results to a healthcare environment identified under very specific conditions.
Additional information
Details
Original published date:
2026-03-19
Alert / recall type Health product recall Category Health products - Medical devices - General hospital and personal use Companies
| Biomedical Data Solutions Limited |
| Millenium Court, Burton On Trent, Staffordshire, United Kingdom, DE14 2WH |
Published by Health Canada Audience General public Healthcare Industry Recall class Type II Recall date
2026-02-19
Identification number RA-81778
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