FDA Device recall Z-2661-2016
SUNRISE instrument
- FDA Device
- Class II
- terminated
- Published 2016-08-31
On 2016-08-31 the FDA classified a Class II recall of SUNRISE instrument by Tecan Us, citing the batteries have the potential to overheating, melt or char.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2661-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-07-25 |
| Published | 2016-08-31 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Tecan Us |
| Distribution | AK, AL, AR, CA, FL, GA, HI, KY, MA, MD, NC, NY, PA, PR, SC, TN, TX, UT, VA |
Product
SUNRISE instrument. The INFINITE F50 instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to obtain information on physiological and pathological states. For applications in human clinical diagnostic uses, only the Magellan Tracker software is intended for the use with the instrument. Software and instrument have been validated for measurement and for the evaluation of qualitative and quantitative Enzyme-linked Immunosorbent Assays (ELISA) according to the scheduled diagnostic parameters and instrument specifications; they are therefore for professional use in in-vitro diagnostics
Reason
The batteries have the potential to overheating, melt or char.
Identifiers
| code_info | Instrument Material #16039400, PC Serial # 2CE4220L6Z, Instrument Serial # 1201008596 and Instrument Material #30087502…Instrument Material #16039400, PC Serial # 2CE4220L6Z, Instrument Serial # 1201008596 and Instrument Material #30087502, PC Serial #2CE3362777, Instrument Serial #1403008116; PC Serial #2CE3461RV1, Instrument Serial #1404001455; PC Serial #2CE3461RVY, Instrument Serial #1404001456; PC Serial #2CE41503MD, Instrument Serial #1405003467; PC Serial #2CE3462FX0, Instrument Serial #1405002373; PC Serial #2CE4220BW9, Instrument Serial #1407000866; PC Serial #2CE42406XP, Instrument Serial #1409007597; PC Serial #CND4426259, Instrument Serial #1412005606; PC Serial #CND442618S, Instrument Serial #1503003902; PC Serial #CND44261R2, Instrument Serial #1504007122; PC Serial #CND44273XJ, Instrument Serial #1504004857; PC Serial #CND5219GYY, Instrument Serial #1506006286; PC Serial #CND5219GYX, Instrument Serial #1509005071; PC Serial #CND5219H21, Instrument Serial #1511009478; PC Serial #CND5219GYN, Instrument Serial #1512005969; PC Serial #CND5219H68, Instrument Serial #1603000018; PC Serial #CND5 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2661-2016%22
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