FDA-Device2018-04-11Class II
Elecsys BRAHMS PCT Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 and K3 EDTA, Li-Heparin).
Roche Diagnostics Corporation
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.
Sold states
US Distribution in states of: CA, FL and IN.
Affected count
47
Manufactured in
9115 Hague Rd, N/A, Indianapolis, IN, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1311-2018Don't want to check this manually?
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