FDA Device recall Z-1970-2015
Infinite 200 PRO in vitro diagnostic
- FDA Device
- Class II
- terminated
- Published 2015-07-08
On 2015-07-08 the FDA classified a Class II recall of Infinite 200 PRO in vitro diagnostic by Tecan Us, citing A firmware bug causes incorrect values to be displayed for specific measured luminescence values.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1970-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-29 |
| Published | 2015-07-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Tecan Us |
| Distribution | US |
Product
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
A firmware bug causes incorrect values to be displayed for specific measured luminescence values.
Identifiers
| code_info | Material Number 30050303. Serial numbers 1501008516 1106001345 1301002808 1302009129 1110007010 1308006467 121…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 10110047 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1970-2015%22
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