Siemens Healthcare recalls Dimension Vista Lactate Dehydrogenase Flex reagent cartridges that may show falsely elevated results when used with Lactic Acid reagents, potentially leading to unnecessary patient tests.
Siemens Healthcare Diagnostics has confirmed that Dimension Vista Lactate Dehydrogenase (LDI) may exhibit an erroneously elevated result when the preceding assay in the reaction cuvette is Lactic Acid (LA). The magnitude of the elevation may be variable. Both quality control and patient samples may be impacted. Incomplete removal of residual lactate dehydrogenase, a component of the LA reagent, has been identified as the cause of the potentially elevated result. A falsely elevated result for lactate dehydrogenase may lead to additional investigations to determine the etiology of tissue damage. Results would be correlated with clinical history and presentation in addition to other diagnostic laboratory testing.
Siemens Healthcare is recalling Dimension Vista Lactate Dehydrogenase (LDI) Flex reagent cartridges that may give falsely high results when used with Lactic Acid reagents. This could lead to unnecessary tests for tissue damage. The issue is caused by incomplete removal of residual lactate dehydrogenase from the previous reagent.
The reagent cartridge may show falsely elevated lactate dehydrogenase levels when used with Lactic Acid reagents. This can lead to unnecessary tests for tissue damage. The problem occurs because some lactate dehydrogenase residue remains from the previous reagent.
Users of the Dimension Vista Lactate Dehydrogenase Flex reagent cartridges for blood tests are affected. Patients with specific blood test procedures using these cartridges are most at risk.
Check for the product code K2054 or material numbers like 10464323, 18240BA, 18199BA, 18162AC, 18155BB, 18106BC, 18073BE, 18036BC, 17342BA on the cartridge. These are used with the Dimension Vista System for blood tests.
Verify the product code or material numbers listed on the cartridge to confirm if it is recalled.
The reagent cartridge may show falsely elevated lactate dehydrogenase results when used with Lactic Acid reagents, potentially leading to unnecessary tests for tissue damage.
It may cause falsely high lactate dehydrogenase results, which could lead to additional tests to determine tissue damage.
Check for the product code K2054 or material numbers like 10464323, 18240BA, 18199BA, 18162AC, 18155BB, 18106BC, 18073BE, 18036BC, 17342BA on the cartridge.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0499-2019 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0499-2019 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.
