CLASS II Device recall · Reported 8 Jul 2015 · FDA Enforcement Report

Infinite F500, in vitro diagnostic recalled by Tecan US

Tecan US is recalling Infinite F500, in vitro diagnostic, distributed nationwide in the US. The recall was initiated on 29 May 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMaterial Number 30019337. Serial numbers 1212004416 1009002605 612000003 811002510 712004158 906000965 902005109 912003472 1103002583 1411007090 704000003 702000001 708000500 1003004146 1109000103 1412005124 805001219 911005026 708005532 705007195 810000248 1010001663 712004152 708005533 1412005709 1103003780 706004455 608000002 908000185 1009002604 1308001035 804005914 1311007600 804000984 705009034 1309003195 801008055 706007961 901006341

Quantity recalled868 in total

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-1967-2015
FDA event ID: 71352
Recalling firm: Tecan US, Morrisville, NC
Classification: Class II
Status: Terminated
Recall initiated: 29 May 2015
FDA classified: 2 Jul 2015
Reported: 8 Jul 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Test Kits & Diagnostics

Timeline

29 May 2015	Recall initiated by company
2 Jul 2015	Classified by FDA	+34 days
8 Jul 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

A firmware bug causes incorrect values to be displayed for specific measured luminescence values.

Product as listed by the FDA

Infinite F500, in vitro diagnostic. Product Usage: The Tecan Infinite F500 is a multifunctional microplate reader with injector option. The Infinite F500 provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The Infinite F500 is intended as a general purpose laboratory instrument for professional use, supporting common microplate conforming to the ANS/SBS standards.

Where it was distributed

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

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Iowa Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine

Questions about this recall

Why was it recalled?

A firmware bug causes incorrect values to be displayed for specific measured luminescence values.

Which lots are affected?

Material Number 30019337. Serial numbers 1212004416 1009002605 612000003 811002510 712004158 906000965 902005109 912003472 1103002583 1411007090 704000003 702000001 708000500 1003004146 1109000103 1412005124 805001219 911005026 708005532 705007195 810000248 1010001663 712004152 708005533 1412005709 1103003780 706004455 608000002 908000185 1009002604 1308001035 804005914 1311007600 804000984 705009034 1309003195 801008055 706007961 901006341

Where was it sold?

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

4 other products · FDA event 71352

Reported	Class	Recall	Company	Reason	Where
8 Jul 2015	CLASS II	Infinite M1000 PRO in vitro diagnostic recalled by Tecan US	Tecan US	Potency & Assay	Nationwide
8 Jul 2015	CLASS II	Infinite M1000 in vitro diagnostic recalled by Tecan US	Tecan US	Other	Nationwide
8 Jul 2015	CLASS II	Infinite 200 PRO in vitro diagnostic recalled by Tecan US	Tecan US	Other	Nationwide
8 Jul 2015	CLASS II	Infinite vitro diagnostic recalled by Tecan US	Tecan US	Other	Nationwide

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