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).
This recall has been terminated (originally issued August 25, 2016).
- Company
- Tecan Us, Inc.
- Recall Initiated
- July 25, 2016
- Posted
- August 25, 2016
- Terminated
- January 23, 2017
- Recall Number
- Z-2666-2016
- Quantity
- 1 unit
- Firm Location
- Morrisville, NC
- Official Source
- View on FDA website ↗
Reason for Recall
The batteries have the potential to overheating, melt or char.
Distribution
Worldwide Distribution - US including AK, AL, AR, CA, FL, GA, HI, KY, MA, MD, NC, NY, PA, PR, SC, TN, TX, UT, VA. International account: Canada.
Lot / Code Info
Instrument Material #30087532, PC Serial #2CE4240D4X, Instrument Serial # 1411004534.
Root Cause
Nonconforming Material/Component
Action Taken
Tecan contacted all customers by Safety Announcement, via certified mail starting July 25, 2016. The letter identified the product, the problem, and the action to be taken by the customer. Because affected batteries pose a fire and burn hazard, it is extremely important that customers check whether their battery is affected. Customers were advised to go immediately to the HP Battery Recall website at: http://www.HP.com/go/batteryprogram2016 to check if their battery is affected by this recall. Customers were also advised to complete and return the Customer Response Form at QA@tecan.com or fax it to 919-287-2961. Customers with questions should contact HP at 1-888-202-4320 or Tecan Technical Service's Helpdesk at 800-832-2687, option 1.