The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2662-2016·Announced 2016-08-31

Tecan Infinite 200 Absorbance Reader Recalled for Battery Overheating Risk

Tecan US, Inc. is recalling 5 units of the Tecan Infinite 200 absorbance reader 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 is classified as FDA Class II, and the hazard involves batteries overheating, melting, or charring, which presents a significant risk of fire or property damage.

Plain-English summary

Tecan US, Inc. is recalling 5 units of the Tecan Infinite 200, 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 were distributed worldwide, including in the United States and Canada. The recall covers specific instrument and PC serial numbers listed in the agency's documentation. The instrument is intended for professional use in in-vitro diagnostics, specifically for measuring light absorbance of liquid media.

Consumers and laboratories with these specific units should stop using the instrument and contact Tecan US, Inc. for instructions on how to proceed with the recall.

The recalled product

Product
Tecan Infinite 200. The SUNRISE 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
5

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 #30050303
  • PC Serial numbers: CND5219H0B
  • Instrument Serial #1208002673
  • PC Serial numbers: CND44273RW
  • Instrument Serial #1211001074
  • PC Serial numbers: CND44273SC
  • Instrument Serial #1309006773
  • PC Serial numbers: 2CE3461RNR
  • Instrument Serial #1311008588
  • PC Serial numbers: 2CE33625KT
  • Instrument Serial #1401006356
  • PC Serial numbers: 2CE33626Q9
  • Instrument Serial #1403000833
  • PC Serial numbers: 2CE3461RR3
  • Instrument Serial #1403003928
  • PC Serial numbers: 2CE33625M4
  • Instrument Serial #1403005482
  • PC Serial numbers: 2CE41503JF
  • Instrument Serial #1405000420
  • PC Serial numbers: CND5219H4R

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 →

Related recalls

Same manufacturer · Tecan US, Inc.

See all →

Same hazard · fire

See all →

Similar recalls