Device 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.
Z-2416-2015
Product summary
- Event
- Event 71710
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1032
- Official record key
device-enforcement:Z-2416-2015
Official wording
Reason: A change in the concentration of N-acetylcysteine (NAC) that may cause interference for the ADVIA¿ Chemistry Systems Acetaminophen assay for certain lots.
Code information: 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.
Distribution pattern: 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.
Derived failure modes
-
Unknown
A change in the concentration of N-acetylcysteine (NAC) that may cause interference for the ADVIA¿ Chemistry Systems Acetaminophen assay for certain lots.