Reported Jun 17, 2020 · Terminated

ADVIA Chemistry Enzymatic Creatinine_2, Siemens Material Number 10335869, UDI Number 00630414526690 - Product Usage:…

Siemens Healthcare Diagnostics, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Siemens Healthcare Diagnostics, Inc. · 500 Gbc Dr · Newark, DE · 19702-2466

Is this the product you have?

    • ADVIA Chemistry Enzymatic Creatinine_2
    • Siemens Material Number 10335869
    • UDI
  • Number 00630414526690 - Product Usageuse in the quantitative determination of creatinine in human serum, plasma, and urine for the diagnosis and treatment of renal disease
Lot codes and dates
    • Lot #s 53149
    • 53150
    • 53151
    • 53152
    • 53941
    • 53942
    • 53943
    • 53944
    • 54354
    • 54371
    • 54372
    • 54373
    • 54374
Amount recalled
1006

This recall covers 6 products

The agency filed one notice per product. You are reading one of them; the other 5 are below.

Where it was sold

Why it was recalled

The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 20, 2021 · Data as of Sep 19, 6:14 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.