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Recall Observatory FDA recall evidence

Device product

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.

Z-2541-2018

April 02, 2018

Class II

Product summary

Firm
Bio-Rad Laboratories Inc
Event
Event 80403
Status
Terminated
Classification
Class II
Quantity
153
Official record key
device-enforcement:Z-2541-2018

Official wording

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 information: 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 pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.