Infinite 200 in vitro diagnostic — Class II medical device recall Z-1971-2015
Terminated recall by Tecan US, Inc., reported 2015-07-08, distributed nationwide. A firmware bug causes incorrect values to be displayed for specific measured luminescence values.
| Recall number | Z-1971-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tecan US, Inc., Morrisville, NC, United States |
| Recall initiated | 2015-05-29 |
| Classified | 2015-07-02 |
| Reported by FDA | 2015-07-08 |
| Terminated | 2017-08-18 |
| Distributed | Nationwide (US) |
| Quantity | 868 in |
| Reason classes | software |
| Serial numbers | 1001007577, 1001007581, 1002001897, 1002003711, 1002003718, 1003000498, 1003000501, 1003000503, 1003000506, 1003004213, 1003006072, 1003008005, 1003008013, 1004000452, 1004000460, 1004001238, 1004004207, 1005004932, 1005007024, 1005007027, 1006000210, 1006002104, 512000007, 512000011, 512000025 and 219 more |
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 for recall
A firmware bug causes incorrect values to be displayed for specific measured luminescence values.
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-1971-2015. 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.