The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2661-2016·Announced 2016-08-31

Tecan INFINITE F50 Absorbance Reader Recalled for Battery Overheating Risk

Tecan US, Inc. is recalling 19 INFINITE F50 absorbance readers 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 risk of fire and burn injury due to batteries overheating, melting, or charring, which aligns with the rubric criterion for significant injury or property damage reports.

Plain-English summary

Tecan US, Inc. is recalling 19 units of the INFINITE F50 instrument, a 96-well absorbance reader used for in-vitro diagnostic analysis. The recall is due to a safety hazard where the instrument's batteries have the potential to overheat, melt, or char.

The affected units were distributed worldwide, including in the United States and Canada. The recall covers specific instruments identified by their PC Serial Numbers and Instrument Serial Numbers, such as PC Serial # 2CE4220L6Z and Instrument Serial # 1201008596.

Users of the INFINITE F50 instrument should stop using the device and contact Tecan US, Inc. for further instructions on how to proceed with the recall.

The recalled product

Product
SUNRISE 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
19

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 (20)

  • Instrument Material #16039400
  • PC Serial # 2CE4220L6Z
  • Instrument Serial # 1201008596 and Instrument Material #30087502
  • PC Serial #2CE3362777
  • Instrument Serial #1403008116
  • PC Serial #2CE3461RV1
  • Instrument Serial #1404001455
  • PC Serial #2CE3461RVY
  • Instrument Serial #1404001456
  • PC Serial #2CE41503MD
  • Instrument Serial #1405003467
  • PC Serial #2CE3462FX0
  • Instrument Serial #1405002373
  • PC Serial #2CE4220BW9
  • Instrument Serial #1407000866
  • PC Serial #2CE42406XP
  • Instrument Serial #1409007597
  • PC Serial #CND4426259
  • Instrument Serial #1412005606
  • PC Serial #CND442618S

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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