Siemens Healthcare recalls Atellica IM CKMB Master Curve Material (Cat No. 10995534) due to potential bias compared to internal standards in diagnostic testing. Affected kits may give inaccurate results for ADVIA Centaur CKMB assays.
A potential bias was identified with certain kits compared to the internal standards.
Siemens Healthcare is recalling Atellica IM CKMB Master Curve Material (Cat No. 10995534) because it may cause inaccurate test results when used with the ADVIA Centaur CKMB assay. This could lead to incorrect diagnoses if the material is used without proper calibration.
The recalled material may produce biased results compared to internal standards when used in the ADVIA Centaur CKMB assay. This could lead to incorrect test outcomes if the material is not properly calibrated before use. The issue affects the accuracy of the diagnostic test results.
Users of the Atellica IM CKMB Master Curve Material for in vitro diagnostic testing with the ADVIA Centaur system are affected. Laboratory personnel and healthcare providers using this specific kit for CKMB testing are most at risk of inaccurate results.
Check for the product code 10995534 on the kit. The lot number 11803 with expiry date February 10, 2019 is affected. This material is used for in vitro diagnostic testing with the ADVIA Centaur CKMB assay.
Verify the product code 10995534 and lot number 11803 on the kit to confirm if it is affected.
The recall is due to a potential bias in the Atellica IM CKMB Master Curve Material compared to internal standards, which could lead to inaccurate test results for the ADVIA Centaur CKMB assay.
The official recall notice does not specify a remedy or action steps for affected kits.
The recall indicates a potential risk of inaccurate results, but the official notice does not state that the product is unsafe to use.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0117-2019 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0117-2019 from Siemens Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
