The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1968-2015·Announced 2015-07-08

Tecan Infinite M1000 PRO Microplate Reader Recalled for Firmware Bug

Tecan US, Inc. is recalling 868 Infinite M1000 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. The hazard involves a firmware bug causing incorrect data display, which is a functional defect without reported physical injury or death, fitting the Moderate severity criteria for low-risk contamination or functional issues.

Plain-English summary

Tecan US, Inc. is recalling 868 units of the Infinite M1000 PRO 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 products were distributed nationwide in the United States, including the District of Columbia. The recall covers units with Material Number 30063849 and specific serial numbers listed in the agency's records.

The Infinite M1000 PRO is a multifunctional laboratory instrument intended for professional use. It provides measurements for absorbance, fluorescence intensity, fluorescence polarization, and luminescence. Users should check their device's serial number against the recall list to determine if it is affected.

The recalled product

Product
Infinite M1000 PRO in vitro diagnostic. Product Usage: The Tecan Infinite M1000 PRO is a multifunctional monochromator based microplate reader that provides high performance for the vast majority of todays microplate applications and research. In addition to offering…
Manufacturer
Tecan US, Inc.
Category
Medical Device — Laboratory Equipment
Hazard
Affected units
868

Distribution

Distributed nationwide across the United States.

The notice also names 42 states specifically:

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.

See all 5 products in this recall →

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