{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "165373", "product_res_number": "Z-2541-2018", "event_date_initiated": "2018-04-02", "event_date_created": "2018-07-25", "recall_status": "Terminated", "res_event_number": "80403", "product_code": "JJE", "product_description": "PR4100 Microplate Reader US, Catalog Number 45591587\n\nProduct Usage:\nThe 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.", "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", "firm_fei_number": "3008272466", "recalling_firm": "Bio-Rad Laboratories Inc", "address_1": "6565 185th Ave NE", "city": "Redmond", "state": "WA", "postal_code": "98052-5039", "additional_info_contact": "Tina Cuccia\n510-724-7000", "reason_for_recall": "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.", "root_cause_description": "Device Design", "action": "An Urgent Product Correction notification letter dated 4/2/18 was distributed to customers. The letter instructed customers to check the system and confirm it is labeled as shown in the letter. Then complete the attached form, indicating if the system includes a D-Link Brand USB hub, and fax or email back the form to Bio-Rad as soon as possible. If needed, a Bio-Rad Technical Support Representative will contact you shortly to arrange for replacement of the hub.", "product_quantity": "153", "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.", "openfda": { "k_number": [ "K944028", "K885289", "K890183", "K884378", "K904220", "K822465", "K854138", "K782014", "K831649", "K953239", "K770679", "K950353", "K974779", "K942364", "K922139", "K841916", "K821335", "K130276", "K771345", "K760642", "K872103", "K933548", "K860080", "K073370", "K772319", "K863531", "K800085", "K883533", "K895423", "K862235", "K923060", "K860647", "K890184", "K864849", "K933703", "K943493", "K921661", "K873617", "K771245", "K860021", "K843082", "K810596", "K811194", "K962125", "K903071", "K962235", "K830318", "K944093", "K803267", "K854243", "K811919", "K920402", "K890927", "K902689", "K831477", 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