Medica recalls Wash Kit REF 10680 (Lots 16279, 17045, 17215) due to inconsistent lipase test results when triglyceride assays are run together. This can cause inaccurate patient test results.
The firm has initiated a field recall of the Wash1 Kit REF 10680 due to reported inconsistent Lipase values when analyzing patient samples. The firm's internal investigation identified the underlying cause to be an ineffective wash solution resulting in an interference carryover from the triglyceride (TRIG) assay if they are on the same worklist.
Medica is recalling a specific wash kit (REF 10680) because it can cause inconsistent lipase test results when used with triglyceride assays. This may lead to inaccurate patient test results if the kit is used incorrectly.
The wash solution can cause interference between lipase and triglyceride tests if run on the same worklist. This happens because the triglyceride assay reagent contains lipase, which the wash solution doesn't fully remove.
Healthcare labs using Medica's EasyRA analyzer with this wash kit for lipase testing. Labs that run triglyceride assays on the same worklist as lipase tests are most at risk.
Check for the wash kit with reference number REF 10680 and lots numbers 16279, 17045, or 17215. This kit is used with Medica's EasyRA clinical chemistry analyzer for lipase testing.
Look for the lot numbers 16279, 17045, or 17215 on the wash kit packaging.
The wash kit can cause inconsistent lipase test results when used with triglyceride assays on the same worklist due to interference from the triglyceride assay reagent.
No, this is a technical issue that affects test accuracy, not physical safety.
It can lead to inaccurate lipase test results if triglyceride assays are run on the same worklist as lipase tests.
We’ve drafted a message you can send Medica to request your refund or repair — edit it as you like.
Subject: Recall Z-1149-2018 — Medica Medica Hello, I own a Medica that is covered by recall Z-1149-2018 from Medica. 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.
