Infinite M1000 in vitro diagnostic — Class II medical device recall Z-1969-2015
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-1969-2015 |
|---|---|
| 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 | 1001001581, 1001006205, 1001006206, 1001007641, 1001007642, 1002002702, 1002002703, 1002002705, 1003000532, 1003005106, 1003005107, 1003005108, 1004003572, 1005002244, 1005008053, 1005008055, 1005008056, 1005008057, 1006007069, 1006007071, 1007003513, 1007005488, 1007007320, 1007007321, 1008001833 and 64 more |
Product
Infinite M1000 in vitro diagnostic. Product Usage: The Tecan Infinite M1000 is a multifunctional monochromator based microplate reader that provides high performance for the vast majority of todays microplate applications and research. Besides offering absorbance and fluorescence intensity measurements, the Infinite M1000 allows the measurement of fluorescence polarization and luminescence. The Infinite M1000 is also robotic compatible and offers a built-in stacker option as well as a external injector module. The Infinite M1000 is intended as a general purpose laboratory instrument for professional use, supporting common 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-1969-2015. 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.