Hydroflex ELISA The HYDROFLEX is a plate washer for 96-well… — Class II medical device recall Z-2666-2016
Terminated recall by Tecan US, Inc., reported 2016-08-31, distributed in AK, AL, AR, CA, FL, GA, HI, KY…. The batteries have the potential to overheating, melt or char.
| Recall number | Z-2666-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tecan US, Inc., Morrisville, NC, United States |
| Recall initiated | 2016-07-25 |
| Classified | 2016-08-25 |
| Reported by FDA | 2016-08-31 |
| Terminated | 2017-01-23 |
| Distributed | AK, AL, AR, CA, FL, GA, HI, KY, MA, MD, NC, NY, PA, PR, SC, TN, TX, UT, VA |
| Countries outside the US | CA |
| Quantity | 1 units |
| Reason classes | device malfunction |
| Serial numbers | 1411004534, 2CE4240D4X |
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 for recall
The batteries have the potential to overheating, melt or char.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2666-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.