Inova Diagnostics Aptiva CTD Essential Controls Safety Action
Summary
ANSM published safety alert R2608798 informing medical biology laboratories of a quality control recall by Inova Diagnostics for Aptiva CTD Essential Controls used in autoimmune testing. The manufacturer's safety action letter was distributed to affected users on 14 April 2026. Laboratories should review the recalled controls and contact Inova Diagnostics directly for guidance.
What changed
ANSM has published safety alert R2608798 regarding a quality control recall by Inova Diagnostics for Aptiva CTD Essential Controls. These are control materials used with the Aptiva instrument system for autoimmune disease testing. The manufacturer has initiated a safety action and issued a letter to affected laboratory users.\n\nMedical biology laboratories using Aptiva CTD Essential Controls should review the manufacturer's safety letter, assess the impact on their testing operations, and contact Inova Diagnostics directly for replacement or corrective measures. The recall affects the quality control materials used to verify test system performance in autoimmune diagnostics.
What to do next
- Review ANSM safety alert R2608798
- Consult Inova Diagnostics safety letter dated 14/04/2026
- Contact Inova Diagnostics for guidance on affected controls
Archived snapshot
Apr 14, 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.
Information n° R2608798 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 Inova Diagnostics.
Les utilisateurs concernés ont reçu le courrier ci-joint.
Cette action de sécurité est enregistrée à l’ANSM sous le n° R2608798.
Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Consultez le courrier de la société Inova Diagnostics (14/04/2026)
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