Elecsys BRAHMS PCT Immunoassay for the in vitro quantitative determination of PCT (procalciton...
FDA Recall #Z-1311-2018 — Class II — December 22, 2017
Product Description
Elecsys BRAHMS PCT Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 and K3 EDTA, Li-Heparin).
Reason for Recall
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.
Recalling Firm
Roche Diagnostics Corporation — Indianapolis, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
47
Distribution
US Distribution in states of: CA, FL and IN.
Code Information
Elecsys BRAHMS PCT: 07301715190 Lot number 204084
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated