The Recall Desk
Agency classClass IIIOur severity:LowFDA (Devices)·Z-0992-2015·Announced 2015-01-21

Tecan Infinite 200PRO Microplate Reader Recalled for Firmware Error

Tecan US, Inc. is recalling Infinite 200PRO microplate readers due to an incorrect firmware version installed on the devices.

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 recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a software configuration error rather than a physical safety hazard.

Plain-English summary

Tecan US, Inc. is recalling the Infinite 200PRO multifunctional microplate reader. The recall is due to an incorrect firmware version (E.027) being installed instead of the correct version (V2.00).

The affected devices were distributed worldwide, including in the United States, Maryland, Hong Kong, South Korea, and the United Kingdom. Specific material number 30050303 and lot numbers 1010005108, 1012003953, 1108005760, 1306007560, and 1311008591 are involved in this recall.

Users of these laboratory instruments should contact Tecan US, Inc. for instructions on how to resolve the firmware issue.

The recalled product

Product
Infinite 200PRO 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…
Manufacturer
Tecan US, Inc.
Category
Medical Device — Laboratory Equipment
Hazard

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 (5)

  • Material number: 30050303
  • Lot numbers: 1010005108
  • 1012003953
  • 1108005760
  • 1306007560 and 1311008591.

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 →

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