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Siemens Atellica CH CK_L Creatine Kinase Reagent Recall

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Published April 7th, 2026
Detected April 7th, 2026
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Summary

ANSM has recorded a product recall by Siemens Healthcare Diagnostics for its Atellica CH Creatine Kinase (CK_L) biochemical reagent. The recall affects 847 units distributed to medical biology laboratories. This safety action is registered as ANSM reference number R2609472, with the manufacturer issuing recall correspondence on 07/04/2026.

What changed

Siemens Healthcare Diagnostics is conducting a targeted lot removal of its Atellica CH CK_L (Creatine Kinase) reagent due to identified safety or quality concerns. The recall covers 847 units, with affected laboratories receiving direct notification from the manufacturer including return/replacement instructions.

Medical biology laboratories in possession of affected units must immediately cease using the recalled reagent for patient testing and follow Siemens Healthcare Diagnostics instructions for returning or replacing the product. Laboratories that have already performed tests using the affected reagent should assess potential impact on patient results and consider appropriate follow-up measures. Failure to address a medical device recall could result in unreliable diagnostic results with direct patient safety implications.

What to do next

  1. Cease using affected Atellica CH CK_L reagent immediately
  2. Follow Siemens Healthcare Diagnostics return/replacement instructions
  3. Review patient test results if affected reagent was used prior to recall notification

Source document (simplified)

A+ A-

Rappel n° R2609472 destiné aux laboratoires d'analyses de biologie médicale L'ANSM a été informée de la mise en œuvre d’un retrait de lots effectué par la société Siemens Healthcare Diagnostics.

Les utilisateurs concernés ont reçu le courrier ci-joint.

Cette action de sécurité est enregistrée à l’ANSM sous le n° R2609472. Pour toute question, merci de vous adresser directement à l’émetteur de l’action de sécurité. Téléchargez le courrier de la société Siemens Healthcare Diagnostics (07/04/2026)

Named provisions

Biochimie - Reactif Atellica CH Créatine Kinase CK_L - Siemens Healthcare Diagnostics

Source

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

Classification

Agency
ANSM
Published
April 7th, 2026
Instrument
Notice
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
R2609472
Docket
R2609472

Who this affects

Applies to
Healthcare providers Medical device makers
Industry sector
3345 Medical Device Manufacturing 6211 Healthcare Providers
Activity scope
Medical Device Distribution In Vitro Diagnostics
Threshold
847 units
Geographic scope
France FR

Taxonomy

Primary area
Medical Devices
Operational domain
Compliance
Topics
Healthcare Public Health

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