Z-0992-2015Class III

Infinite 200PRO The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The...

Name: Z-0992-2015 Infinite 200PRO The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The...
Creator: Tecan US, Inc.
Published: 2014-11-10
License: https://open.fda.gov/license/

Tecan U.S. / initiated 2014-11-10 / Terminated / root cause: manufacturing process

FDA source

Tecan US, Inc. began a recall of Infinite 200PRO The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The Infinite 200 provides high performance for the vast... on 2014-11-10. FDA classified it as Class III and gives the reason as "Incorrect lumi firmware version installed (E.027 instead of V2.00)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0992-2015
Classification: Class III
Status: Terminated
Initiated: 2014-11-10
Posted: 2015-01-15
Terminated: 2015-12-21
Recalling firm: Tecan U.S.
Product: Infinite 200PRO 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.
Product code: KHO Fluorometer, For Clinical Use
Reason for recall: Incorrect lumi firmware version installed (E.027 instead of V2.00)
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Tecan sent an Urgent Field Corrective Action letter dated October2014, to all affected consignees by via FedEx on/or about November 10, 2014. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed not to use te kinetic luminescence measurement workflow requiring movement of th eplate transport out during kinectice measurements until the firmware has been upgraded to current version 2.0. A Tecan service representative will contact you to arrange a time to install the firmware. Additionally, they may want to review prior measurement results obtained with this workflow. Customers with questions were advised to contacte their local Tecan Helpdesk. For questions regarding this recall call 919-361-5200, ext 19524.
Distribution: Worldwide Distribution - USA including MD and Internationally to Hong Kong, South Korea and the UK.
Product codes and lots: Material number: 30050303, Lot numbers: 1010005108, 1012003953, 1108005760, 1306007560 and 1311008591.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0992-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0991-2015	Class III	Terminated	Voluntary: Firm initiated	2015-01-21	2015-01-15
Z-0992-2015	Class III	Terminated	Voluntary: Firm initiated	2015-01-21	2015-01-15

Product code KHO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)