The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2665-2016·Announced 2016-08-31

Tecan Infinite M1000 PRO Microplate Reader Recalled for Battery Overheating Risk

Tecan US, Inc. is recalling 11 Infinite M1000 PRO microplate readers because their 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 presents a significant fire and burn injury risk, meeting the criteria for a Severe (Score 4) classification.

Plain-English summary

Tecan US, Inc. is recalling 11 units of the Tecan Infinite M1000 PRO multifunctional monochromator-based 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, and VA) and Canada. The specific units are identified by Instrument Material #30063849 and various PC and Instrument serial numbers listed in the official recall notice.

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

The recalled product

Product
Tecan Infinite M1000 PRO The Tecan Infinite M1000 PRO is a multifunctional monochromator-based microplate reader that provides high performance for the vast majority of todays microplate applications and research. In addition to offering absorbance and fluorescence intensity…
Manufacturer
Tecan US, Inc.
Category
Medical Device — Laboratory Instrument
Hazard
Affected units
11

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 #30063849
  • PC Serial # 2CE3362609
  • Instrument Serial #1110008219
  • PC Serial # CND5219H33
  • Instrument Serial #1204007588
  • PC Serial # 2CE3462FTJ
  • Instrument Serial #1301009861
  • PC Serial # 2CE3462FTD
  • Instrument Serial #1311007574
  • PC Serial #2CE33625KP
  • Instrument Serial #1404000703
  • PC Serial #2CE33625ND
  • Instrument Serial #1404000704
  • PC Serial #2CE41503PY
  • Instrument Serial #1406000407
  • PC Serial #2CE41503NW
  • Instrument Serial #1408001415
  • PC Serial #2CE41503K0
  • Instrument Serial #1407003406
  • PC Serial #CND5219GY7

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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