The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2666-2016·Announced 2016-08-31

Tecan Hydroflex ELISA Plate Washer Recalled for Battery Overheating Risk

Tecan US, Inc. is recalling Hydroflex ELISA plate washers because the batteries may overheat, melt, or char.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a battery that can overheat, melt, or char, which presents a significant fire and burn hazard. This aligns with the rubric criteria for 'Severe' severity involving significant injury or property-damage risks.

Plain-English summary

Tecan US, Inc. is recalling the Hydroflex ELISA plate washer. This instrument is used for in-vitro diagnostic processing of samples from the human body, specifically for Enzyme-linked Immunosorbent Assays (ELISA).

The recall is being issued because the batteries in the instrument have the potential to overheat, melt, or char. The affected units are identified by Instrument Material #30087532, PC Serial #2CE4240D4X, and Instrument Serial # 1411004534.

The product was distributed worldwide, including in the United States and Canada. Users should stop using the instrument and contact the recalling firm for instructions on how to proceed.

The recalled product

Product
Hydroflex ELISA The HYDROFLEX is a plate washer for 96-well microplates. The instrument is intended to be used primarily in in-vitro diagnostic processing of samples from the human body to obtain information on physiological and pathological states. Software and instrument have…
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 #30087532
  • PC Serial #2CE4240D4X
  • Instrument Serial # 1411004534.

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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