Reported Aug 26, 2015 · Terminated

ADVIA Chemistry Acetaminophen reagents; for in vitro diagnostic use in the quantitative determination of acetaminophen…

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 Ms 514 · Newark, DE · 19702-2466

Is this the product you have?

  • ADVIA Chemistry Acetaminophen reagents; for in vitro diagnostic use in the quantitative determination of acetaminophen in human serum and plasma (lithium heparin) on ADVIA Chemistry systems.
Lot codes and dates
    • Catalog Number 07989138
    • Siemens Material Number (SMN) 10327381
  • Lot Numbers
    • 46251
    • 46564
    • 46369
    • 46370
    • 46619
    • 46782
    • 47001
    • 47157
    • 47558
    • with expiration dates June 30
    • 2015 through April 30
    • 2016
Amount recalled
1032

Where it was sold

  • Nationwide

Why it was recalled

A change in the concentration of N-acetylcysteine (NAC) that may cause interference for the ADVIA¿ Chemistry Systems Acetaminophen assay for certain lots.

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

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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 1, 2016 · Data as of Sep 19, 6:49 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.