Devices

Device Recall Infinite 200

  • 모델명 / 제조번호(시리얼번호)
    Material Number 30016056.  Serial numbers 608000038 708002670 809004233 702000023 805005669 811008399 705000576 708002669 607000020 701000018 701000019 912003459 912003460 910001503 612000022 609000040 1003008013 707005001 811005538 908007099 912002703 903002644 906005248 706007165 710000525 708005547 606000059 812003043 1004000452 806006568 702000055 912002709 708004538 607000002 910004667 811002997 702000005 906002532 907001839 803002342 606000017 602000009 603000019 804005274 806006009 903000369 912001128 807006555 803006110 712003370 812003592 611000052 606000023 910001497 702000035 711008973 710006304 806006565 609000014 811001743 903000617 811008162 710006302 602000010 606000014 906005245 603000022 712003104 1006000210 1003004213 612000021 1001007577 606000057 606000060 807004920 702000033 810003503 907001838 912004835 712004196 812001432 605000009 807004921 910001506 905004260 611000001 1003000506 606000002 612000031 705009140 807004933 603000016 604000016 910006599 606000041 606000058 809003657 810007441 604000023 906005250 703000026 711003508 805005672 903005273 1005004932 711011958 712004195 802004558 703000009 1002003718 607000038 703000030 901006989 512000025 608000016 608000017 512000011 711011784 804000313 1004001238 711005298 706004794 901004028 906000751 906000752 607000036 610000003 912004849 709000580 612000033 812004163 710000341 709002724 1004000460 812001429 606000016 801004189 603000051 810000172 608000031 904003884 805005673 706002156 912004620 1003000498 706004795 907003871 608000007 706002155 703000027 605000031 809003661 1002003711 611000013 907003869 605000022 911000116 910001504 1004004207 907001844 909003373 1001007581 812003078 908006434 809004133 701000025 606000043 707005005 1005007027 910004659 1003008005 905000129 804002911 706001227 703000005 705008369 707005006 706004797 604000014 910001508 812003041 906006724 911005649 809002413 801004398 703000012 804007741 910008851 911005664 1005007024 811001744 602000041 604000007 809000305 706005557 806006007 901006987 912004844 701000016 1002001897 605000012 805004762 809006161 708005898 903005272 611000027 712002390 912004328 602000011 907003870 906005249 801008029 605000030 903005182 912004848 806004296 912002702 1003006072 809004232 609000034 709002268 1003000501 803006117 1003000503 705000578 702000048 912000536 706004792 901000869 809000302 907003872 912004614 1006002104 612000025 901005069 711003366 906004540 603000018 911002915 609000008 512000007 601000035 804000312 602000031
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution in the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, NE NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, including DC
  • 제품 설명
    Infinite 200 in vitro diagnostic. || Product Usage: || The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The Infinite 200 provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The Infinite 200 PRO has been designed as a general purpose laboratory instrument for professional use, supporting common 6 to 384 well microplates conforming to the ANS/SBS standards.
  • Manufacturer
    Tecan US, Inc.
  • 1 Event

제조사

Tecan US, Inc.
  • 제조사 주소
    Tecan US, Inc., 9401 Globe Center Drive, Suite 140, Morrisville NC 27560
  • 제조사 모회사 (2017)
    Tecan Group AG
  • Source
    USFDA

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Device Recall Infinite 200 PRO
  • 모델명 / 제조번호(시리얼번호)
    Material Number 30050303.  Serial numbers 1501008516 1106001345 1301002808 1302009129 1110007010 1308006467 1211001078 1204007050 1401006368 1409008005 1412005114 1009003261 1210009373 1104000436 1009006192 1305001434 1310010334 1402000382 1410007778 1208006946 1007000392 1305010270 1405002521 1304005224 1401004534 1405006969 1111000103 1210007330 1502007386 1401007346 1412005118 1203003218 1007005229 1301007222 1006004109 1307006588 1311000218 1112005413 1305008099 1208009225 1212000034 1301009476 1311003918 1206001011 1212000035 1211009784 1403007992 1207007478 1201006124 1408006474 1408006475 1304000220 1401006366 1301009472 1401009553 1305004119 1108003415 1311000214 1309003843 1408002770 1403004653 1009006194 1306007913 1111007888 1009004379 1302001636 1105001261 1106002181 1208005752 1307006587 1112005785 1212004214 1402003539 1307001047 1410002321 1401009545 1409005578 1407000606 1112004304 1011004727 1011004728 1411004683 1407000614 1009004894 1009004895 1412005121 1105005792 1208002653 1101006577 1310006280 1202000758 1210005464 1405002507 1212003129 1404001420 1406007259 1411004208 1008006784 1301009464 1309003841 1405000435 1402006217 1201002015 1502003021 1211001056 1202007079 1305010252 1211007583 1402003536 1111009129 1311008588 1410002324 1010001510 1109001150 1304002474 1409002244 1409003931 1409003939 1409005599 1409005600 1412005115 1208007659 1208005753 1410004931 1206006103 1404001416 1304000215 1305008098 1405006967 1308006472 1403005482 1405002509 1211001181 1303009359 1309006759 1102001378 1310009096 1204007054 1308003257 1208005761 1201006112 1402006220 1406006649 1406006650 1408006482 1503000055 1307004560 1308003263 1111002443 1106005622 1301009473 1211009803 1203002542 1405002955 1407000830 1310001807 1211001182 1307002800 1210007324 1110002600 1202006470 1409003932 1409003933 1409003934 1412005692 1009003260 1108003821 1112003276 1009001469 1105007942 1108000027 1108003820 1311001420 1404001433 1104000437 1111001299 1308005785 1302001638 1006002113 1410002329 1212000019 1408002772 1009004900 1308005784 1405005827 1405005828 1405005832 1406007252 1406007253 1406007254 1406009467 1406009468 1406009469 1312001489 1312001490 1401004538 1007002013 1110002615 1209004250 1409008009 1208005762 1009004896 1210007325 1109006201 1211001061 1204007052 1403008259 1412005270 1412005271 1412005272 1412005273 1309001980 1204001408 1306007897 1205002713 1302009128 1305004114 1408001815 1401007348 1102005862 1206006707 1308005782 1308006464 1008008069 1405000423 1105003473 1007000393 1409001305 1305001438 1402006218 1207002826 1105002132 1112002744 1408006476 1412004378 1409005576 1102005863 1106005614 1107000316 1109001151 1203008288 1208002672 1308005783 1311006286 1007002029 1107004613 1307005690 1311002613 1009006202 1009006816 1007005234 1010005100 1104000432 1103007238 1111000095 1305004723 1407000604 1410007766 1206000041 1112003274 1201004206 1208007649 1409001306 1305000358 1206002904 1210009360 1108005462 1206006105 1503002991 1310003976 1409002250 1501003733 1109006207 1405006968 1410002326 1201004188 1407004538 1305001432 1306001009 1110002616 1203005901 1501003727 1111004457 1111007891 1304005214 1201006104 1303009354 1104000433 1403000833 1208009069 1211007584 1410007771 1401000958 1112003277 1210005471 1102001395 1305004113 1309008853 1209000271 1108003412 1210007320 1302001629 1111007885 1205002711 1310009539 1310009540 1406002034 1409003929 1210007319 1503001521 1108005762 1212000053 1108003424 1210009361 1303007865 1401007345 1302009135 1212000054 1503004891 1101009077 1201006100 1307001052 1210007334 1405006966 1407000605 1111009100 1304005212 1407006394 1410007769 1107000313 1403000840 1007006136 1204007055
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution in the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, NE NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, including DC
  • 제품 설명
    Infinite 200 PRO in vitro diagnostic. || Product Usage: The Tecan Infinite 200 PRO is a multifunctional microplate reader with injector option. The Infinite 200 PRO provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The Infinite 200 PRO has been designed as a general purpose laboratory instrument for professional use, supporting common 6 to 384 well microplates conforming to the ANS/SBS standards.
  • Manufacturer
    Tecan US, Inc.
Device Recall Infinite 200 PRO
  • 모델명 / 제조번호(시리얼번호)
    Instrument Material #30050303, PC Serial numbers: CND5219H0B, Instrument Serial #1208002673; PC Serial numbers: CND44273RW, Instrument Serial #1211001074; PC Serial numbers: CND44273SC, Instrument Serial #1309006773; PC Serial numbers: 2CE3461RNR, Instrument Serial #1311008588; PC Serial numbers: 2CE33625KT, Instrument Serial #1401006356; PC Serial numbers: 2CE33626Q9, Instrument Serial #1403000833; PC Serial numbers: 2CE3461RR3, Instrument Serial #1403003928; PC Serial numbers: 2CE33625M4, Instrument Serial #1403005482; PC Serial numbers: 2CE41503JF, Instrument Serial #1405000420; PC Serial numbers: CND5219H4R, Instrument Serial #1405002510; PC Serial numbers: 2CE42406YJ, Instrument Serial #1406009472; PC Serial numbers: 2CE4220LGP, Instrument Serial #1410002321; PC Serial numbers: 2CE424072G, Instrument Serial #1410004940: PC Serial numbers: 2CE4240DJ7, Instrument Serial #1411008631; PC Serial numbers: 2CE424071M, Instrument Serial #1412005274; PC Serial numbers: CND44273XR, Instrument Serial #1503001536; PC Serial numbers: CND5219H1S, Instrument Serial #1503002986; PC Serial numbers: CND44262KJ, Instrument Serial #1503004890; PC Serial numbers: CND442625D, Instrument Serial #1501008506; PC Serial numbers: CND442627J, Instrument Serial #1501008513; PC Serial numbers: CND44273SB, Instrument Serial #1505009092; PC Serial numbers: CND442626B, Instrument Serial #1509001022; PC Serial numbers: CND5219H11, Instrument Serial #1509008146; PC Serial numbers: CND5219H6D, Instrument Serial #1511009716; PC Serial numbers: 2CE3461RSX, Instrument Serial #1512005211; PC Serial numbers: 2CE3381HT1, Instrument Serial #1601005141 and PC Serial numbers: CND5219H2K, Instrument Serial #1510004918.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US including AK, AL, AR, CA, FL, GA, HI, KY, MA, MD, NC, NY, PA, PR, SC, TN, TX, UT, VA. International account: Canada.
  • 제품 설명
    Infinite 200 PRO || The Tecan Infinite 200 PRO is a multifunctional microplate reader with injector option. The Infinite 200 PRO provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The Infinite 200 PRO has been designed as a general purpose laboratory instrument for professional use, supporting common 6 to 384-well microplates conforming to the ANSI/SBS standards.
  • Manufacturer
    Tecan US, Inc.
Device Recall Infinite 200
  • 모델명 / 제조번호(시리얼번호)
    Material number: 30016056, Lot numbers: 708004532, 810007441, 906000758.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including MD and Internationally to Hong Kong, South Korea and the UK.
  • 제품 설명
    Infinite 200 || The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The Infinite 200 provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The infinite 200 has been designed as a general purpose laboratory instrument for professional use, supporting common 6 to 384-well microplates conforming to the ANSI/SBS standards.
  • Manufacturer
    Tecan US, Inc.
Device Recall Infinite 200 PRO
  • 모델명 / 제조번호(시리얼번호)
    Material number: 30050303, Lot numbers: 1010005108, 1012003953, 1108005760, 1306007560 and 1311008591.
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including MD and Internationally to Hong Kong, South Korea and the UK.
  • 제품 설명
    Infinite 200PRO || The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The Infinite 200 provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The infinite 200 has been designed as a general purpose laboratory instrument for professional use, supporting common 6 to 384-well microplates conforming to the ANSI/SBS standards.
  • Manufacturer
    Tecan US, Inc.