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Siemens Healthcare Diagnostics, Inc. recalls ADVIA Chemistry Acetaminophen reagents; for in vitro diagnostic use in the quantitative determination of acetaminophen i
Recalled August 26, 2015 · FDA recall Z-2416-2015 · Siemens Healthcare Diagnostics
Hazard
A change in the concentration of N-acetylcysteine (NAC) that may cause interference for the ADVIA¿ Chemistry Systems Acetaminophen assay for certain lots. · FDA Class II
Units
1032
Sold at
Worldwide Distribution - US (nationwide) and to the countries of : Canada, Netherlands, Great Britain, Norway, Sweden, Spain, Italy, Germany, France, Finland, Belgium, Portugal, Czech Republic, Israel, Poland, Turkey and Bahrain.
Description
A change in the concentration of N-acetylcysteine (NAC) that may cause interference for the ADVIA¿ Chemistry Systems Acetaminophen assay for certain lots.
Product
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.
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →