Tecan Infinite M1000 Microplate Reader Recalled for Firmware Bug
Tecan US, Inc. is recalling 868 Infinite M1000 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves incorrect data display which could lead to erroneous research or diagnostic conclusions, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Tecan US, Inc. is recalling 868 units of the Infinite M1000 in vitro diagnostic 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 across the United States, including the District of Columbia. The recall covers units with Material Numbers 30034301 and 30061442, along with a specific list of serial numbers provided in the agency documentation.
Users of these instruments should contact Tecan US, Inc. for instructions on how to resolve the firmware issue. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible health adverse consequences, or where the probability of serious adverse health consequences is remote.
The recalled product
- 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…
- 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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