Siemens Healthcare recalls HDLC Flex reagent cartridges that may cause inaccurate cholesterol tests. Affected units have specific Siemens Material Numbers and lot numbers. Contact for replacement.
Dimension Vista¿ High Density Lipoprotein Cholesterol (HDLC) Potential for Erroneous Result. If an HDLC QC or patient result is obtained without an Abnormal Reaction [E145]: flag, a falsely depressed or elevated result ranging from -90% to 133% may be observed.
Siemens Healthcare is recalling HDLC Flex reagent cartridges that can cause inaccurate cholesterol test results. This could lead to incorrect health assessments if used without the proper flagging system.
The reagent cartridges may produce test results that are too low or too high by up to 133% if the system doesn't flag an abnormal reaction. This could lead to incorrect health assessments.
People who use Siemens Dimension Vista HDLC reagent cartridges for cholesterol testing. Those with specific Siemens Material Numbers or lot numbers are most at risk.
Check for Siemens Material Number (SMN) 10464340 or lot number 21250BA with expiration date 2022-09-07. The product is sold under catalog number K3048A.
Look for Siemens Material Number 10464340 or lot number 21250BA with expiration date 2022-09-07.
The test may show cholesterol levels that are too low or too high by up to 133% if the system doesn't flag an abnormal reaction.
Check for Siemens Material Number 10464340 or lot number 21250BA with expiration date 2022-09-07.
The recall does not specify a remedy, so contact Siemens Healthcare for guidance.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0089-2023 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0089-2023 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
