BEUDAMED
    FDA Recall Terminated

    Atellica CH 930 Analyzer

    Recall: Z-0581-2020 · Initiated September 23, 2019

    Recall

    Recall Number
    Z-0581-2020
    Event Number
    83946
    Firm
    Siemens Healthcare Diagnostics, Inc.
    FEI Number
    2432235
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    September 23, 2019
    Terminated
    July 6, 2022
    Address
    511 Benedict Ave, Tarrytown, NY, 10591-5005

    Description

    Atellica CH 930 Analyzer

    Reason

    Potential for calibration error resulting in QC failures after the calibration run with QC and patient results being 5 times higher.

    Action

    Siemens issued an Urgent medical Device Correction, (UMDC ASW19-06.A.US) and Urgent Field Safety Notification (UFSN ASW19-06.A.OUS) to all affected Customers via Certified Mail (domestic) and e-mail (international) beginning on 2019-09-23. It included the following instructions to the user: Actions to be Taken by the Customer 1. Do not order Reagent Pack Calibration (C0 Adjust) while the Reagent Lot calibration is in progress. 2. Always run QC after calibration before running patient samples. If QC is ordered with calibration and it recovers out of range high, the calibration status will be 'Awaiting Acceptance'. Reject and re-order the calibration. - Please review this letter with your Medical Director. - Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. - If you have received any complaints of illness or adverse events associated with the product listed immediately contact your local Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative. Please retain this letter with your laboratory records and forward this letter to those who may have received this product.

    Distribution

    Distributed to accounts located in AL AZ AR CA CO FL GA IL IN IA KS KY LA MA MI MN MS NE NV NH NJ NM NY NC OH OR PA SC TN TX UT WA WV DC PR. Foreign distribution to AR AU AT BS BD BE BR BG CA CL CO CW CZ DK EG FI FR DE GR HU IN IR IE IL IT JP KW LV MY MX NL NG NO CN PK PH PL PT QA KR RO RU SA SG SK ZA ES SE CH TW TH TR AE GB UY VN.

    Quantity

    1432