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).
Class I - DangerousWhat Should You Do?
- Check if you have this product: Instrument Material #30087532, PC Serial #2CE4240D4X, Instrument Serial # 1411004534.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Tecan US, Inc.
- Reason for Recall:
- The batteries have the potential to overheating, melt or char.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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).
Product Codes/Lot Numbers:
Instrument Material #30087532, PC Serial #2CE4240D4X, Instrument Serial # 1411004534.
Distribution:
Distributed in: US, AK, AL, AR, CA, FL, GA, HI, KY, MA, MD, NC, NY, PA, PR, SC, TN, TX, UT, VA
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2666-2016
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