CLASS III Device recall · Reported 21 Jan 2015 · FDA Enforcement Report
Infinite 200 The Tecan Infinite 200 is a multifunctional recalled
Tecan US is recalling Infinite 200 The Tecan Infinite 200 is a multifunctional microplate reader with injector, distributed nationwide in the US. The recall was initiated on 10 Nov 2014 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0991-2015
- FDA event ID
- 69739
- Recalling firm
- Tecan US, Morrisville, NC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 10 Nov 2014
- FDA classified
- 15 Jan 2015
- Reported
- 21 Jan 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 10 Nov 2014 | Recall initiated by company | |
| 15 Jan 2015 | Classified by FDA | +66 days |
| 21 Jan 2015 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect lumi firmware version installed (E.027 instead of V2.00)
Product as listed by the FDA
Infinite 200 The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The Infinite 200 provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The infinite 200 has been designed as a general purpose laboratory instrument for professional use, supporting common 6 to 384-well microplates conforming to the ANSI/SBS standards.
Where it was distributed
Worldwide Distribution - USA including MD and Internationally to Hong Kong, South Korea and the UK.
Questions about this recall
Is Infinite 200 The Tecan Infinite 200 is a multifunctional microplate reader with injector recalled?
Yes. Tecan US recalled Infinite 200 The Tecan Infinite 200 is a multifunctional microplate reader with injector on 10 Nov 2014. The recall is Class III and its status is Terminated. Recall number Z-0991-2015.
Why was it recalled?
Incorrect lumi firmware version installed (E.027 instead of V2.00)
Which lots are affected?
Material number: 30016056, Lot numbers: 708004532, 810007441, 906000758.
Where was it sold?
Worldwide Distribution - USA including MD and Internationally to Hong Kong, South Korea and the UK.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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