Tecan Infinite F500 Microplate Reader Recalled for Firmware Bug
Tecan US, Inc. is recalling 868 Infinite F500 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 may cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote. The hazard is a data integrity issue (incorrect display) rather than a direct physical injury risk, fitting the Moderate category for a software defect in a diagnostic instrument.
Plain-English summary
Tecan US, Inc. is recalling 868 units of the Infinite F500 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 are distributed nationwide in the United States, including the District of Columbia. The specific units are identified by Material Number 30019337 and a list of specific serial numbers provided in the recall notice.
Users of these devices should stop using them and contact Tecan US, Inc. for instructions on how to resolve the issue. The recall is intended to prevent the use of inaccurate data in laboratory research and diagnostics.
The recalled product
- Product
- Infinite F500, in vitro diagnostic. Product Usage: The Tecan Infinite F500 is a multifunctional microplate reader with injector option. The Infinite F500 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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