Siemens recalls Dimension Vista ALPI Flex reagent cartridges that may produce low outlier results. Affected lots have expired or were sold between 2009-2020. No action needed for low risk results.
Low outlier resultsgenerated with Alkaline Phosphatase (ALPI) Flex reagent cartridge.The maximum difference observed with a patient sample was approximately -27% at a concentration of 129 U/L (2.15 ukat/L). The low outlier results are generated from the last five (5) tests of the well
Siemens is recalling certain ALPI Flex reagent cartridges that may produce low outlier results in blood tests. This could lead to inaccurate test results, but the risk is low and no action is required.
The reagent cartridges may generate low outlier results when testing blood samples, particularly in the last five tests of a well. The maximum difference observed was about -27% at a specific concentration level.
Lab users who purchased the affected Siemens Dimension Vista ALPI Flex reagent cartridges between 2009 and 2020. Patients using these cartridges for blood tests may see slightly lower results than expected.
Check for lot numbers 19247AB, 19282BB, 19330BD, or expanded lots listed in the recall notice. These cartridges were sold between 2009 and 2020 with specific expiration dates.
Look for the lot number on the cartridge label, which may be 19247AB, 19282BB, 19330BD, or other expanded lots listed in the recall.
No action is needed as the risk is low and the results are unlikely to cause serious harm.
The affected cartridges have specific lot numbers and were sold between 2009 and 2020 with particular expiration dates.
The results may be slightly lower than expected, but this is a low risk and does not require immediate action.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0134-2021 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0134-2021 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.
