Z-1969-2015Class II

Infinite M1000 in vitro diagnostic

Name: Z-1969-2015 Infinite M1000 in vitro diagnostic
Creator: Tecan US, Inc.
Published: 2015-05-29
License: https://open.fda.gov/license/

Tecan U.S. / initiated 2015-05-29 / Terminated / root cause: design

FDA source

Tecan US, Inc. began a recall of Infinite M1000 in vitro diagnostic. Product Usage: The Tecan Infinite M1000 is a multifunctional monochromator based microplate reader that provides high... on 2015-05-29. FDA classified it as Class II and gives the reason as "A firmware bug causes incorrect values to be displayed for specific measured luminescence values". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1969-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-29
Posted: 2015-07-02
Terminated: 2017-08-18
Recalling firm: Tecan U.S.
Product: Infinite M1000 in vitro diagnostic. Product Usage: The Tecan Infinite M1000 is a multifunctional monochromator based microplate reader that provides high performance for the vast majority of todays microplate applications and research. Besides offering absorbance and fluorescence intensity measurements, the Infinite M1000 allows the measurement of fluorescence polarization and luminescence. The Infinite M1000 is also robotic compatible and offers a built-in stacker option as well as a external injector module. The Infinite M1000 is intended as a general purpose laboratory instrument for professional use, supporting common microplates conforming to the ANS/SBS standards.
Product code: KHO Fluorometer, For Clinical Use
Reason for recall: A firmware bug causes incorrect values to be displayed for specific measured luminescence values.
Root cause tag: design
FDA root cause: Device Design
Action: Tecan sent an Urgent Field Corrective Action letter dated May 29, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the attached Customer Response Form. For questions contact your local Tecan Helpdesk.
Quantity in commerce: 868 in total
Distribution: US Nationwide Distribution in the states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, NE NH, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, including DC
Product codes and lots: Material Number 30034301 and 30061442. Serial numbers 904004848 807001164 1003005106 808056058 1006007069 1108006370 906001927 811005550 1002002705 1007007321 1110004989 1009005297 910008892 1005008056 1103008195 1009003991 912003102 1007005488 912003960 1008001833 808052054 1005002244 1103001072 909005818 1005008057 1010005921 1004003572 1103008191 1001006206 809004189 907004270 1006007071 1010001688 1010001689 1110004987 1112000054 1107006152 1103008189 902000004 810003913 908006454 1002002702 912003958 1009002602 1007003513 1001007642 1110006961 911008985 908001687 1011003332 909007802 901005834 901005835 1009007093 906000659 812003360 1110004988 1009002603 1001006205 1003005108 1005008055 1112000053 1001001581 1005008053 1003000532 909000550 911000226 910004186 1009003980 1110006962 907000033 907000720 908004917 1001007641 910008890 808052053 808054758 901005836 911006512 1002002703 1003005107 1106008462 912000502 1010005918 909000551 807003935 807003936 907004267 1007007320

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1969-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1967-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-07-02
Z-1968-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-07-02
Z-1969-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-07-02
Z-1970-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-07-02
Z-1971-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-07-02

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)