Reported Aug 31, 2016 · Terminated
Hydroflex ELISA The HYDROFLEX is a plate washer for 96-well microplates. The instrument is intended to be used…
Tecan US, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Tecan US, Inc. · 9401 Globe Center Drive · Morrisville, NC · 27560
Is this the product you have?
- 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).
- Lot codes and dates
Instrument Material #30087532PC Serial #2CE4240D4XInstrument Serial # 1411004534
- Amount recalled
- 1 unit
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
The batteries have the potential to overheating, melt or char.
This product could cause temporary or reversible health problems — stop using it.
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