Tecan Infinite 200 Microplate Reader Recalled for Firmware Bug
Tecan US, Inc. is recalling 868 Infinite 200 microplate readers because a firmware bug causes incorrect luminescence values to be displayed.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves incorrect data display rather than a direct physical safety risk like injury or death, fitting the criteria for moderate severity involving potential adverse health consequences or temporary harm.
Plain-English summary
Tecan US, Inc. is recalling 868 units of the Infinite 200 multifunctional microplate reader. The recall is due to a firmware bug that causes incorrect values to be displayed for specific measured luminescence values.
The affected devices were distributed nationwide in the United States, including the District of Columbia. The recall covers specific serial numbers listed in the agency's documentation.
Users of the Infinite 200 should contact Tecan US, Inc. for instructions on how to resolve the firmware issue. The device is intended for professional laboratory use and supports common 6 to 384 well microplates.
The recalled product
- 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.…
- Manufacturer
- Tecan US, Inc.
- Affected units
- 868
Distribution
Part of a larger recall action
This product is one of 5 recalled by Tecan US, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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