Siemens Healthcare recalls Dimension Vista ALTI assay (K2143/10635: false drug results risk. Affected units may show incorrect levels for sulfasalazine/sulfapyridine.
Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely depressed results.
Siemens Healthcare is recalling Dimension Vista ALTI assay kits because they can give false results for sulfasalazine and sulfapyridine drugs. This could lead to incorrect medical decisions if used without proper testing.
The assay may show incorrect drug levels when testing patients taking sulfasalazine or sulfapyridine. This could lead to wrong medical decisions if the false results are not recognized.
People using this assay for blood, urine, or cerebrospinal fluid tests who take sulfasalazine or sulfapyridine medications. Those with regular medical monitoring are most at risk.
Check for product number K2143/10635565 on the assay kit. The recall applies to all lots of this specific assay.
Look for product number K2143/10635565 on the assay kit.
The assay may show incorrect drug levels for sulfasalazine or sulfapyridine, leading to wrong medical decisions.
The recall does not provide a fix; users should check if they have the affected product number and contact Siemens Healthcare if needed.
Check for product number K2143/10635565 on the assay kit. The recall applies to all lots of this specific assay.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1656-2018 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-1656-2018 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.
