Siemens Atellica CH CK_L Creatine Kinase Reagent Recall
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
- Cease using affected Atellica CH CK_L reagent immediately
- Follow Siemens Healthcare Diagnostics return/replacement instructions
- Review patient test results if affected reagent was used prior to recall notification
Source document (simplified)
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)
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