FDA Device recall Z-2666-2016
Hydroflex ELISA The HYDROFLEX is a plate washer for 96-well microplates
- FDA Device
- Class II
- terminated
- Published 2016-08-31
On 2016-08-31 the FDA classified a Class II recall of Hydroflex ELISA The HYDROFLEX is a plate washer for 96-well microplates 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-2666-2016 |
| 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
Hydroflex ELISA The HYDROFLEX is a plate washer for 96-well microplates. The instrument is intended to be used primarily in in-vitro diagnostic processing of samples from the human body to obtain information on physiological and pathological states. Software and instrument have been validated for processing of qualitative and quantitative Enzyme-linked Immunosorbent Assays (ELISA) and therefore are intended for professional use in in-vitro diagnostics. The instrument has not been validated for other areas of application not mentioned in the Intended Use (e.g. veterinary, biopharma).
Reason
The batteries have the potential to overheating, melt or char.
Identifiers
| code_info | Instrument Material #30087532, PC Serial #2CE4240D4X, Instrument Serial # 1411004534. |
|---|
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-2666-2016%22
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