Siemens recalls Dimension Vista LOCI CA 15-3 Flex reagent cartridges due to potential negative bias in patient samples, which could delay cancer treatment decisions. Affected units have specific lot numbers and expiration dates.
Negative bias with patient samples. The mean patient sample bias range from -26% to -33%,potential risk of delay in appropriate treatment and management decisions.
Siemens Healthcare is recalling Dimension Vista LOCI CA 15-3 Flex reagent cartridges that may show negative bias in patient samples. This could lead to delayed cancer treatment decisions if the test results are not accurate.
The reagent cartridges can produce test results that are too low by up to 33% compared to actual patient levels. This negative bias might cause doctors to delay or miss appropriate cancer treatment decisions.
Patients using this specific cancer biomarker test cartridge for CA 15-3 monitoring are most at risk. Healthcare providers who use the recalled cartridges for diagnostic testing may also be affected.
Check for the Siemens Material Number (SMN) or Ref Catalog Number 10464344/K6456. Look for lot numbers: 21340BB (exp 2022-12-06), 22049BC (exp 2023-02-18), or 22112BF (exp 2023-04-20).
Identify the lot number on the cartridge label to determine if it is affected (21340BB, 22049BC, or 22112BF).
The cartridges may show negative bias in patient samples, meaning test results could be up to 33% lower than actual patient levels, potentially delaying cancer treatment decisions.
Check the lot number on the cartridge: 21340BB (exp 2022-12-06), 22049BC (exp 2023-02-18), or 22112BF (exp 2023-04-20).
The recall does not require immediate stop use; affected units should be checked against the listed lot numbers.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1648-2022 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1648-2022 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.
