Siemens Healthcare recalls ADVIA Chemistry Lipase products due to failed calibrations and imprecise patient sample results. Affected units may cause inaccurate pancreatic disease diagnoses.
Firm has received customer complaints regarding failed calibrations and increased imprecision of quality control and patient samples when using this product.
Siemens Healthcare is recalling ADVIA Chemistry Lipase products because they have failed calibrations and produce imprecise results for patient samples. This could lead to inaccurate diagnoses of pancreatic conditions like acute pancreatitis.
The product has failed calibrations and increased imprecision in quality control and patient samples. This can lead to inaccurate measurements for pancreatic conditions such as acute pancreatitis.
Laboratory users and healthcare professionals who rely on this product for pancreatic disease testing. Those using the device for patient diagnostics are most at risk of inaccurate results.
Check for the product name 'ADVIA Chemistry Lipase', reference number 01984894, model B01-4840-01, or Siemens Material No. 10311896. The recall covers lot 485700.
Verify the product name, reference number, model, and lot number to confirm if it's affected.
The firm has received customer complaints about failed calibrations and increased imprecision of quality control and patient samples.
The recall does not specify a remedy, so check product details to confirm if it's affected.
The recall describes failed calibrations and imprecise results, not a direct safety hazard like injury or fire.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1363-2020 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1363-2020 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.
