The Recall Desk
SevereFDA (Devices)·Z-2660-2016·Announced 2016-08-31

Tecan Infinite F50 Absorbance Reader Recalled for Battery Overheating Risk

Tecan US, Inc. is recalling Infinite F50 absorbance readers because the batteries may overheat, melt, or char.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk of battery overheating, melting, or charring, which presents a significant fire and burn hazard.

Plain-English summary

Tecan US, Inc. is recalling the Infinite F50 instrument, a 96-well absorbance reader used for in-vitro diagnostic analysis. The recall is due to a defect where the instrument's batteries have the potential to overheat, melt, or char.

The affected units are distributed worldwide, including in the United States and Canada. The specific unit identified in the recall notice has Instrument Material #330087508, PC Serial # CND5219H07, and Instrument Serial #1508007738. The instrument is intended for professional use in in-vitro diagnostics, specifically for the evaluation of Enzyme-linked Immunosorbent Assays (ELISA).

Users of the Infinite F50 instrument should stop using the device and contact Tecan US, Inc. for further instructions regarding the recall.

The recalled product

Product
Infinite F50 instrument. The INFINITE F50 instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to obtain
Manufacturer
Tecan US, Inc.
Category
Medical Device — Laboratory Equipment
Hazard
Affected units
1

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 (3)

  • Instrument Material #330087508
  • PC Serial # CND5219H07
  • Instrument Serial #1508007738.

Distribution

Distributed in 19 states:

Part of a larger recall action

This product is one of 7 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 7 products in this recall →

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