Infinite 200 The Tecan Infinite 200 is a multifunctional microplate… — Class III medical device recall Z-0991-2015
Terminated recall by Tecan US, Inc., reported 2015-01-21. Incorrect lumi firmware version installed (E.027 instead of V2.00)
| Recall number | Z-0991-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tecan US, Inc., Morrisville, NC, United States |
| Recall initiated | 2014-11-10 |
| Classified | 2015-01-15 |
| Reported by FDA | 2015-01-21 |
| Terminated | 2015-12-21 |
| Countries outside the US | GB, HK, KR |
| Quantity | 8 units |
| Reason classes | software |
| Lot numbers | 708004532, 810007441, 906000758 |
Product
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.
Reason for recall
Incorrect lumi firmware version installed (E.027 instead of V2.00)
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0991-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.