FDA-Device2016-05-25Class II
ADVIA Chemistry Triglyceride_2, concentrated; TRIG_c; Catalog # SMN # 10697575. For in vitro diagnostic use in the quantitative measurement of triglycerides in human serum and plasma on ADVIA Chemistry systems.
Siemens Healthcare Diagnostics, Inc.
Hazard
Siemens Healthcare Diagnostics has confirmed the ADVIA Chemistry Triglyceride concentrated reagent (TRIG_c) does not meet Instructions For Use (IFU) linearity claims at the upper limit of the assay range as it approaches end of shelf life for lots # 348297 and 359932.
Sold states
Worldwide Distribution -- USA, including the states of CA, TN, UT, OK, FL, MI, MN, NY, CT, NC, KS, TX, CO, WA, NM, and OR; and, the countries of Austria, Australia, Belgium, Brazil, Bulgaria, Denmark, Estonia, France, Germany. Great Britain, Italy, Latvia, Netherland, Norway, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Czech Republic, India, New Zealand, Thailand, Turkey, and Russian Fed.
Affected count
7,433 units (4,228 for lot 348297 and 3,199 for lot # 359932)
Manufactured in
511 Benedict Ave, N/A, Tarrytown, NY, United States
Products
ADVIA Chemistry Triglyceride_2, concentrated; TRIG_c; Catalog # SMN # 10697575. For in vitro diagnostic use in the quantitative measurement of triglycerides in human serum and plasma on ADVIA Chemistry systems.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1670-2016Don't want to check this manually?
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