Hydroflex ELISA The HYDROFLEX is a plate washer for 96-well microplates. The instrument is intended to be used primarily

FDA device recall Z-2666-2016 · posted 2016-08-25 · Terminated

Recall details

Recalling firm

Tecan US, Inc.

Reason for recall

The batteries have the potential to overheating, melt or char.

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

LXG

Quantity affected

1 unit

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.

Date initiated

2016-07-25

Date posted

2016-08-25

Date terminated

2017-01-23

Location

Morrisville, NC