FDA-Device2015-08-26Class II
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.
Siemens Healthcare Diagnostics, Inc.
Hazard
A change in the concentration of N-acetylcysteine (NAC) that may cause interference for the ADVIA¿ Chemistry Systems Acetaminophen assay for certain lots.
Sold states
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.
Affected count
1032
Manufactured in
500 Gbc Dr Ms 514, PO BOX 6101, Newark, DE, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2416-2015Don't want to check this manually?
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