FDA Device recall Z-1971-2015
Infinite 200 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 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-1971-2015 |
| 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 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.
Reason
A firmware bug causes incorrect values to be displayed for specific measured luminescence values.
Identifiers
| code_info | Material Number 30016056. Serial numbers 608000038 708002670 809004233 702000023 805005669 811008399 705000576…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 10030 |
|---|
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-1971-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.