Siemens Healthcare recalls Dimension Lipase Flex Reagent Cartridges (model 10460277) with specific lot numbers due to inconsistent test results. Affected users should check their lot numbers and contact Siemens for guidance.
There is lot to lot variability for QC and patient results when using the identified reagent cartridge lots.
Siemens Healthcare is recalling Dimension Lipase Flex Reagent Cartridges with certain lot numbers because they can cause inconsistent test results. This affects lab users who rely on these cartridges for lipase testing.
The reagent cartridges can have inconsistent performance across different production batches, leading to unreliable lipase test results. This variability may affect the accuracy of patient diagnoses and treatment decisions.
Lab users who purchased the Dimension Lipase Flex Reagent Cartridges with lot numbers GD9002, GA9003, GB9032, or GA9038 from the Dimension clinical chemistry system are most at risk. These cartridges are used for lipase testing in blood samples.
Check the lot number on the cartridge label. Affected lots are GD9002, GA9003, GB9032, or GA9038. The product is used with Siemens Dimension clinical chemistry systems for lipase testing.
Look for the lot number on the cartridge label to determine if it is one of the affected lots: GD9002, GA9003, GB9032, or GA9038.
The recall is due to lot-to-lot variability in the reagent cartridges, which can cause inconsistent test results for lipase measurements.
Check the lot number on your cartridge. If it is one of the affected lots, contact Siemens Healthcare for guidance on next steps.
The recall record does not specify a remedy, so users should contact Siemens Healthcare directly for assistance.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0465-2019 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-0465-2019 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.
