Agency classClass IIIOur severity:Low FDA (Devices)·Z-0991-2015·Announced 2015-01-21

Tecan Infinite 200 Microplate Reader Recalled for Incorrect Firmware Version

Tecan US, Inc. is recalling eight Infinite 200 microplate readers because they were shipped with the incorrect lumi firmware version (E.027 instead of V2.00).

The agency’s classification

FDA (Devices): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this recall as Class III, which by definition is unlikely to cause adverse health consequences, aligning with the 'Low' severity rubric for documentation or minor technical issues.

Plain-English summary

Tecan US, Inc. is recalling eight units of the Infinite 200 multifunctional microplate reader. The recall is due to an incorrect lumi firmware version being installed on the devices. The affected units have firmware version E.027 installed, whereas the correct version is V2.00.

The recalled units are identified by material number 30016056 and lot numbers 708004532, 810007441, and 906000758. These instruments were distributed worldwide, including in the United States (specifically Maryland) and internationally to Hong Kong, South Korea, and the United Kingdom. The Infinite 200 is a laboratory instrument designed for professional use, supporting common 6 to 384-well microplates.

The U.S. Food and Drug Administration has classified this recall as Class III. This classification indicates that the use of or exposure to the recalled product is not likely to cause adverse health consequences. Users of these devices should contact Tecan US, Inc. for further instructions regarding the firmware correction.

The recalled product

Product: Infinite 200 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. The infinite 200 has been designed as a…
Manufacturer: Tecan US, Inc.
Category: Medical Device — Laboratory Instrument
Hazard: software-error
Affected units: 8

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

Material number: 30016056
Lot numbers: 708004532
810007441
906000758.

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Same manufacturer · Tecan US, Inc.

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Same hazard · software error