Infinite 200 PRO in vitro diagnostic. Product Usage: The Tecan Infinite 200 PRO is a multif...
FDA Device Recall #Z-1970-2015 — Class II — May 29, 2015
Recall Summary
| Recall Number | Z-1970-2015 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 29, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Tecan US, Inc. |
| Location | Morrisville, NC |
| Product Type | Devices |
| Quantity | 868 in total |
Product Description
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.
Reason for Recall
A firmware bug causes incorrect values to be displayed for specific measured luminescence values.
Distribution Pattern
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
Lot / Code Information
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
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| Z-2664-2016 | Class II | Tecan Infinite M1000 The Tecan Infinite M1000 ... | Jul 25, 2016 |
Frequently Asked Questions
A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.