Reported Oct 28, 2026 · Terminated

Ortho Connect, Model/Catalog No. 6904413, 6904414, 6904415, 6913355, 6904410, 6904411, 6904412, 6993333, 6993332.…

Biomedical Data Solutions Limited

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Biomedical Data Solutions Limited · Millennium Court,First Avenue, Centrum 100 · Burton-on-Trent

Is this the product you have?

- Ortho Connect
- Model/Catalog No. 6904413
- 6904414
- 6904415
- 6913355
- 6904410
- 6904411
- 6904412
- 6993333
- 6993332. Software version V3

Lot codes and dates: 6904413
6904414
6904415
6913355
6904410
6904411
6904412
6993333
6993332
Amount recalled: 57

Why it was recalled

Biomedical Data Solutions is recalling distributed units of the ORTHO CONNECT software due to the software incorrectly rejecting potential discrepant results during the result review process and subsequently exporting the results to the LIS.

This product could cause temporary or reversible health problems — stop using it.

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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