Siemens Healthcare recalls Dimension Vista Enzymatic Creatinine (material 10700444) due to potential NAPQI interference in lab tests. Affected lots listed; no action needed but check if used for creatinine testing.
The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.
Siemens Healthcare is recalling its Dimension Vista Enzymatic Creatinine test kit because it may interfere with certain lab tests due to a chemical called NAPQI. This could lead to inaccurate results for creatinine tests in blood or urine. The recall does not require immediate action but users should check if they have the affected lots.
The test kit contains NAPQI, a chemical byproduct of acetaminophen. When used in lab tests, NAPQI can cause false results in certain chemistry assays, potentially leading to incorrect diagnoses of kidney disease.
Patients using this creatinine test kit for kidney disease diagnosis or treatment. Those who have the specific lot numbers listed in the recall are most at risk.
Check the lot number on the test kit. Affected lots include 20027AC, 19336AA, 19273AA, 19218AB, 19192AB, 19189AA, 19175AA, 20083AA, and 20128AB (updated as of November 2, 2020).
Look for the lot number on the test kit label to determine if it is affected.
No, the recall does not require stopping use. The test kit can still be used for creatinine testing as long as the lot number is not affected.
If you have the affected lot numbers, the test kit may cause inaccurate results in certain lab tests. Contact your lab for guidance on whether to retest.
The official recall does not provide a fix. Users should check if they have the affected lots and contact their lab if they need to retest.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2285-2020 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2285-2020 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.
