BEUDAMED
    FDA Enforcement Class II Terminated

    PR4100 Microplate Reader US, Catalog Number 45591587 Product Usage: The PR4100 Microplate Reader is a 96 well absorbance reader for the measurement of light absorbance (optical density-OD) of liquid media. The instrument is intended to be used primarily for the in vitro diagnostic analysis of samples from the human body to obtain information oh physiological and pathological states.

    Recall: Z-2541-2018 · Reported August 1, 2018

    Enforcement

    Recall Number
    Z-2541-2018
    Event ID
    80403
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bio-Rad Laboratories Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 1, 2018
    Initiation Date
    April 2, 2018
    Classification Date
    July 25, 2018
    Address
    6565 185th Ave NE, N/A, Redmond, WA, 98052-5039, United States

    Description

    PR4100 Microplate Reader US, Catalog Number 45591587 Product Usage: The PR4100 Microplate Reader is a 96 well absorbance reader for the measurement of light absorbance (optical density-OD) of liquid media. The instrument is intended to be used primarily for the in vitro diagnostic analysis of samples from the human body to obtain information oh physiological and pathological states.

    Reason

    The connector of the power supply was capable of fitting other components provided with the system. However, the voltage output of the reader power supply is incompatible with the other component and, if incorrectly connected, could result in irreparable damage to the system.

    Code Info

    UDI: 00847865014151 Serial Numbers: 140600072, 160900991, 161001953, 1112001938, 1112001941 , 1112004075 , 1112004079 , 1112004083 , 1112004084 , 1112004086 , 1112004088 , 1112004093 , 1201003822 , 1201003826 , 1201003827 , 1207001007 , 1207001015 , 1207001017 , 1207001018 , 1208001583 , 1208001584 , 1208001586 , 1208001590 , 1208005236 , 1208005244 , 1208005245 , 1211000978 , 1211000983 , 1211006938 , 1301003205 , 1301003212 , 1303000299 , 1303000300 , 1303000302 , 1303000305 , 1303007688 , 1306003195 , 1307006044 , 1307006045 , 1307006054 , 1307006055 , 1308000967 , 1308000968 , 1308000969 , 1308000971 , 1308000973 , 1308003338 , 1308003341 , 1308003345 , 1308003346 , 1308006670 , 1311008542 , 1311008544 , 1311008546 , 1311008555 , 1311008557 , 1311008562 , 1311008564 , 1311008565 , 1401002580 , 1401002583 , 1401002587 , 1401007785 , 1401007786 , 1401007789 , 1401007792 , 1401007793 , 1404000065 , 1404000066 , 1404000067 , 1404000068 , 1404002677 , 1404002684 , 1404002685 , 1405005640 , 1405005641 , 1405005645 , 1405005648 , 1406000064 , 1406000065 , 1406000066 , 1406000067 , 1406000068 , 1406000070 , 1406000071 , 1406000074 , 1406006883 , 1406006886 , 1407004144 , 1407004145 , 1407004147 , 1407004149 , 1407004151 , 1407004152 , 1410010410 , 1410010415 , 1410010416 , 1411010876 , 1411010877 , 1411010880 , 1412001714 , 1412001716 , 1412001721 , 1501001523 , 1501001526 , 1501001526 , 1501005823 , 1501005824 , 1501005825 , 1501005828 , 1501005829 , 1501005832 , 1506008687 , 1506008690 , 1506008695 , 1510005389 , 1510005393 , 1510005394 , 1510005395 , 1510005397 , 1510005398 , 1510005399 , 1510005414 , 1601001552 , 1601001553 , 1601001559 , 1601001561 , 1601001562 , 1601001563 , 1603001786 , 1603005407 , 1605000088 , 1609000992 , 1609000993 , 1609000994 , 1609000995 , 1609000996 , 1609001301 , 1609001302 , 1609001303 , 1609001304 , 1609001305 , 1609001306 , 1609009231 , 1610001955 , 1701001785 , 1701001788 , 1701004204 , 1701004210 , 1710010533 , 1710010539 , 13060003204 , 16303005411 , s1411010876

    Distribution

    US Nationwide Distribution inn the states of : AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OR, PA, SC, TN, TX, VA, VT, WA, WI, and Puerto Rico.

    Quantity

    153