Food, drugs, devices › Tecan US, Inc.
Device recall: Infinite F500, in vitro diagnostic. Product Usage: The Tecan Infinite F500 is a multifunctional microplate reader with i
FDA enforcement event 71352 is a device recall by Tecan US, Inc. of Morrisville, NC, initiated 29 May 2015 and classified Class II, with 5 product records.
FDA defines Class II as 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. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 18 Aug 2017. Initiation: voluntary: firm initiated. Tecan US, Inc. has 8 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Tecan US, Inc., Morrisville, NC.
Reason for recall
"A firmware bug causes incorrect values to be displayed for specific measured luminescence values."
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,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1967-2015 | 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… | 868 in total | Class II | Terminated | 8 Jul 2015 |
| Z-1968-2015 | Infinite M1000 PRO in vitro diagnostic. Product Usage: 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… | 868 in total | Class II | Terminated | 8 Jul 2015 |
| Z-1969-2015 | 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… | 868 in total | Class II | Terminated | 8 Jul 2015 |
| Z-1970-2015 | Infinite 200 PRO in vitro diagnostic. Product Usage: The Tecan Infinite 200 PRO is a multifunctional microplate reader with injector option. The Infinite 200 PRO provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The Infinite 200 PRO has been… | 868 in total | Class II | Terminated | 8 Jul 2015 |
| Z-1971-2015 | Infinite 200 in vitro diagnostic. Product Usage: 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 PRO has been designed as a… | 868 in total | Class II | Terminated | 8 Jul 2015 |
Context
Other enforcement events for Tecan US, Inc.
All 8 events for Tecan US, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "A firmware bug causes incorrect values to be displayed for specific measured luminescence values."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "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,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 18 Aug 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.