FDAMarch 7, 2016device
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 recall recorded by the U.S. Food & Drug Administration.
The 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.
What to do
FDA enforcement status: Terminated
Brands named
siemens healthcare diagnosticssiemenssiemens healthcare
Recall history
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