Siemens Healthcare recalls Dimension Vista Lipase Flex Reagent Cartridges (model 10461745) with specific lot numbers due to potential QC and patient result variability. Affected units may not provide accurate test results.
There is lot to lot variability for QC and patient results when using the identified reagent cartridge lots.
Siemens Healthcare is recalling Dimension Vista Lipase Flex Reagent Cartridges (model 10461745) with certain lot numbers because they may cause inconsistent test results. This could lead to inaccurate patient measurements if used without proper quality control.
The reagent cartridges have inconsistent performance across different production batches, which can lead to variations in the quality control and patient test results. This variability might affect the accuracy of lipase measurements in blood samples.
Healthcare facilities using the Dimension Vista system with the specified lot numbers of reagent cartridges are affected. Patients receiving tests using these cartridges may be at risk of inaccurate results.
Check the lot number on the cartridge packaging. Affected lots are 18128BA, 18172BA, and 18186BB. These cartridges are used with the Dimension Vista system for lipase testing.
Identify the lot number on the cartridge packaging to determine if it is one of the affected lots: 18128BA, 18172BA, or 18186BB.
The model number is 10461745.
Affected lot numbers are 18128BA, 18172BA, and 18186BB.
The recall is due to lot-to-lot variability in quality control and patient test results.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0466-2019 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0466-2019 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.
