FDADecember 22, 2017device
Elecsys BRAHMS PCT Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 and K3 EDTA, Li-Heparin).
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Product exhibits a decreased recovery of patient samples on the cobas e 801 module compared to the MODULAR ANALYTICS E 170, cobas e 411, 601, and 602 analyzers.
What to do
FDA enforcement status: Terminated
Brands named
roche diagnosticsroche
UPCs
07301715190
Recall history
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