Changeflow GovPing Pharma & Drug Safety ANSM Safety Information for Pre-analytical Tube
Priority review Notice Added Final

ANSM Safety Information for Pre-analytical Tube

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Detected March 25th, 2026
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Summary

The French National Agency for Medicines and Health Products Safety (ANSM) has issued a safety recall (R2607993) for the Vacuette CTAD 3.5ml pre-analytical tube manufactured by Greiner Bio-One. Affected medical laboratories have been notified directly by the manufacturer.

What changed

The ANSM has issued a safety alert (R2607993) concerning the Greiner Bio-One Vacuette CTAD 3.5ml pre-analytical tube. This action is a safety recall initiated by the manufacturer, Greiner Bio-One, and the ANSM has been informed. The alert directs affected parties to communicate directly with the manufacturer for specific details.

Laboratories using these tubes should have received direct communication from Greiner Bio-One. Compliance officers should ensure their facilities have received and acted upon the manufacturer's specific instructions regarding this safety action. Any questions should be directed to Greiner Bio-One, as indicated by the ANSM.

What to do next

  1. Review internal inventory for Greiner Bio-One Vacuette CTAD 3.5ml pre-analytical tubes.
  2. Confirm receipt and understanding of the safety action communication from Greiner Bio-One.
  3. Follow manufacturer's instructions for any necessary actions related to the recalled product.

Source document (simplified)

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Rappel n° R2607993 destiné 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 Greiner Bio-One.

Les utilisateurs concernés ont reçu le courrier ci-joint.

Cette action de sécurité est enregistrée à l’ANSM sous le n° R2607993. Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Téléchargez le courrier de la société Greiner Bio-One (25/03/2026)

Source

Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
ANSM
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Substantive
Document ID
R2607993

Who this affects

Applies to
Healthcare providers
Industry sector
6211 Healthcare Providers
Activity scope
Medical Laboratory Operations Product Safety
Geographic scope
France FR

Taxonomy

Primary area
Healthcare
Operational domain
Compliance
Topics
Medical Devices Product Safety

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