Siemens Healthcare recalls Atel: LDL cholesterol test kits due to potential magnesium result inaccuracies from reagent carryover. Affected kits include all lots with serial number 11097632 and UDI 00630414596181.
Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results
Siemens Healthcare is recalling Atellica LDL cholesterol test kits because reagent carryover may cause inaccurate magnesium results. This could lead to incorrect health assessments if used without proper validation.
Reagent carryover from the LDL cholesterol test can contaminate magnesium measurements, leading to inaccurate results. This may cause misdiagnosis of magnesium levels in blood tests.
Healthcare labs using the Atellica LDL cholesterol test kits are affected. Patients receiving results from these kits may be at risk of incorrect magnesium assessments.
Check for serial number 11097632 or unique device identifier 00630414596181 on the test kit packaging. All lots of the Atellica CH LDL Cholesterol Direct (DLDL) test kits are affected.
Look for serial number 11097632 or unique device identifier 00630414596181 on the test kit packaging.
Reagent carryover from the LDL cholesterol test can cause inaccurate magnesium results, potentially leading to incorrect health assessments.
Check for serial number 11097632 or unique device identifier 00630414596181 on the test kit packaging. All lots of the Atellica CH LDL Cholesterol Direct (DLDL) test kits are affected.
The recall record does not specify a remedy, so no action is required beyond checking if your kit has the affected serial number or UDI.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1268-2023 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1268-2023 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.
