Siemens Healthcare recalls Dimension Enzymatic Creatinine (Material #10471520) due to potential NAPQI interference in lab tests. Affected units may cause inaccurate results for renal disease diagnosis.
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 Dimension Enzymatic Creatinine test kits because they may interfere with certain lab tests. This could lead to inaccurate results for kidney disease diagnosis if used improperly.
The test kit contains NAPQI, a byproduct of acetaminophen. When used in certain lab tests, NAPQI can cause false results in kidney disease screenings. This interference is unlikely to cause harm if the test is used as directed.
Lab technicians and healthcare providers who use these creatinine test kits for kidney disease diagnosis. Patients using the test kits for renal disease monitoring are at minimal risk if the test is used correctly.
Check for Siemens Material Number 10471520 on the kit. The affected lots include FC0324, BB0262, GD0218, GC0184, FB0122, GF1006, FB1050, and EA1102. These kits were sold for renal disease testing.
Look for the lot numbers FC0324, BB0262, GD0218, GC0184, FB0122, GF1006, FB1050, or EA1102 on the test kit.
The test kit may cause interference in certain lab tests due to NAPQI, a metabolite of acetaminophen, which could lead to inaccurate results for kidney disease diagnosis.
No, the recall does not require stopping use. The test kit can still be used if the lab follows proper procedures to avoid interference.
Check the lot number on the kit. If it matches the affected lots listed, contact Siemens Healthcare for guidance on next steps.
We’ve drafted a message you can send Siemens Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2284-2020 — Siemens Healthcare Siemens Healthcare Hello, I own a Siemens Healthcare that is covered by recall Z-2284-2020 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.
