BEUDAMED
    FDA Recall Terminated

    Elecsys BRAHMS PCT Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human serum and plasma (K2 and K3 EDTA, Li-Heparin).

    Recall: Z-1311-2018 · Initiated December 22, 2017

    Recall

    Recall Number
    Z-1311-2018
    Event Number
    79462
    Firm
    Roche Diagnostics Corporation
    FEI Number
    1823260
    Product Code
    PMT
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    December 22, 2017
    Terminated
    April 5, 2019
    Address
    9115 Hague Rd, Indianapolis, IN, 46256-1025

    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

    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.

    Action

    The firm, Roche, sent an "URGENT MEDICAL DEVICE REMOVAL" letter dated December 22, 2017 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: " Immediately discontinue use of Elecsys BRAHMS PCT (catalog number 07301715190) reagent lot number 204084 on the cobas e 801 module. " Discard affected product according to local guidelines. " Complete the attached fax form and fax it to 1-800-722-7222. " File this Urgent Medical Device Removal (UMDR) for future reference. Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDR.

    Distribution

    US Distribution in states of: CA, FL and IN.

    Quantity

    47