Siemens Healthcare recalls Dimension Lipase Flex Reagent Cartridge lot FB8109 due to calibration failure causing positive bias in test results. Affected units may produce inaccurate test results.
Calibration failure - confirmed a positive bias with LIPL lot FB8109 when compared to other Dimension LIPL lots. Lot FB8109 is not meeting Siemens internal specifications for lot-to-lot limits.
Siemens Healthcare is recalling Dimension Lipase Flex Reagent Cartridge lot FB8109 because it has calibration issues that can cause test results to be too high. This could lead to inaccurate medical testing if used without replacement.
The reagent cartridge has a calibration issue that causes test results to be too high (positive bias) when compared to other lots. This means tests might show higher levels of lipase than actually present, potentially leading to inaccurate medical diagnoses.
Users of Dimension Lipase Flex Reagent Cartridge lot FB8109, primarily healthcare facilities and labs that perform medical testing. The risk is low for individual users since the cartridge is used in controlled environments.
Check for the lot number FB8109 on the reagent cartridge. The product was sold with catalog number DF56 and was manufactured on April 19, 2018.
Look for the lot number FB8109 on the reagent cartridge to confirm if it is affected.
The reagent cartridge has a calibration issue that causes test results to be too high (positive bias) when compared to other lots, potentially leading to inaccurate medical testing.
Check the lot number on the cartridge. If it is FB8109, contact Siemens Healthcare for instructions on replacement.
This is a calibration issue that could lead to inaccurate test results, not a physical safety hazard. The risk is low for individual users.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1796-2018 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1796-2018 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.
