Siemens Healthcare recalls Atellica IM CKMB Calibrator kits (Cat No. 10995532) due to potential bias when compared to internal standards. This affects in vitro diagnostic use 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 Calibrator kits because they may show inaccurate results compared to internal standards. This could lead to incorrect diagnostic evaluations for certain blood tests.
The calibrator kits may produce inaccurate results when compared to internal standards, potentially leading to incorrect blood test evaluations. This could affect diagnostic accuracy for certain conditions.
Users of the Atellica IM CKMB Calibrator kits for in vitro diagnostic testing with ADVIA Centaur CKMB assays are affected. Laboratory personnel and healthcare providers using these kits are most at risk.
Check for the product code 10995532 on the kit. The lot numbers 57837A66 and 67443A66 were produced with an expiry date of December 11, 2018.
Verify the product code (10995532) and lot numbers (57837A66 or 67443A66) on the kit.
The recall is due to a potential bias in the calibrator kits when compared to internal standards, which could affect diagnostic accuracy.
The official recall notice does not specify a remedy or action steps beyond checking product details.
The recall indicates a potential issue with accuracy, but the product is not unsafe for normal use. The hazard level is low risk.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0116-2019 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0116-2019 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.
