The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2663-2016·Announced 2016-08-31

Tecan Infinite 200 PRO Microplate Reader Recalled for Battery Overheating

Tecan US, Inc. is recalling 27 Infinite 200 PRO microplate 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 battery defect with the potential to overheat, melt, or char, which poses a risk of fire or burn injury. This aligns with the rubric for significant injury/property-damage reports or structural defects.

Plain-English summary

Tecan US, Inc. is recalling 27 units of the Infinite 200 PRO multifunctional microplate reader. The recall is due to a defect where the batteries have the potential to overheat, melt, or char.

The affected instruments were distributed worldwide, including in the United States (specifically AK, AL, AR, CA, FL, GA, HI, KY, MA, MD, NC, NY, PA, PR, SC, TN, TX, UT, VA) and Canada. The specific instrument serial numbers are listed in the official recall notice.

Consumers should stop using the affected instruments and contact Tecan US, Inc. for instructions on how to proceed with the recall.

The recalled product

Product
Infinite 200 PRO The Tecan Infinite 200 PRO is a multifunctional microplate reader with injector option. The Infinite 200 PRO provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The Infinite 200 PRO has been…
Manufacturer
Tecan US, Inc.
Category
Medical Device — Laboratory Equipment
Hazard
Affected units
27

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 →

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