Ortho Vision Max Immuno-Hematology Device Safety Alert

ANSM Drug & Device Safety Alerts

Published April 1st, 2026

Detected April 1st, 2026

Summary

ANSM issued a safety information notice (Ref. R2608831) regarding a safety action by QuidelOrtho for Ortho Vision Max and Ortho Vision automated immuno-hematology analyzers. Medical analysis laboratories using these devices have received direct correspondence from the manufacturer about the safety measure. Users with questions should contact QuidelOrtho directly.

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What changed

ANSM informed medical biology laboratories of a safety action conducted by QuidelOrtho for their Ortho Vision Max and Ortho Vision automated immuno-hematology analyzers. The safety action is registered under reference number R2608831. A PDF letter from QuidelOrtho dated 01/04/2026 accompanies this notice.

Laboratories using Ortho Vision Max or Ortho Vision devices should review the manufacturer's safety communication and follow any instructions provided. Questions regarding the specific safety measure should be directed to QuidelOrtho as the issuer of the action. ANSM serves as a notifying authority in this instance rather than the primary source of safety instructions.

What to do next

Review the QuidelOrtho safety letter for Ortho Vision Max and Ortho Vision analyzers
Follow any instructions or corrective actions specified in the manufacturer's communication
Direct questions about this safety action to QuidelOrtho directly

Source document (simplified)

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Information n° R2608831 destinée aux laboratoires d'analyses de biologie médicale L'ANSM a été informée de la mise en œuvre d’une action de sécurité effectuée par la société Quidelortho.

Les utilisateurs concernés ont reçu le courrier ci-joint.

Cette action de sécurité est enregistrée à l’ANSM sous le n° R2608831. Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Téléchargez le courrier de la société Quidelortho (01/04/2026)