Tecan Infinite 200 PRO Microplate Reader Recalled for Firmware Bug
Tecan US, Inc. is recalling 868 Infinite 200 PRO 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, which typically indicates a situation where use of the product could cause temporary or medically reversible health consequences. Since the defect involves data accuracy in a research instrument rather than direct physical harm to a patient, and no injuries are reported, it fits the Moderate category for a precautionary recall of a professional device.
Plain-English summary
Tecan US, Inc. is recalling 868 units of the Infinite 200 PRO in vitro diagnostic microplate reader. The product is a multifunctional laboratory instrument used for research and professional applications, supporting common 6 to 384 well microplates.
The recall is due to a firmware bug that causes incorrect values to be displayed for specific measured luminescence values. This defect may lead to inaccurate data in laboratory research.
The affected units were distributed nationwide in the United States, including the District of Columbia. Users should check their serial numbers against the list provided in the official recall notice to determine if their instrument is affected.
The recalled product
- Product
- Infinite 200 PRO in vitro diagnostic. Product Usage: The Tecan Infinite 200 PRO is a multifunctional microplate reader with injector option. The Infinite 200 PRO provides high performance for the vast majority of todays microplate applications and research and is robotic…
- 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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