Recall Z-2666-2016 ยท LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Tecan US, Inc.
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 ar
| Date | Aug 25, 2016 (initiated Jul 25, 2016) |
| Status | Terminated |
| Reason | The batteries have the potential to overheating, melt or char. |
| Root cause | Nonconforming Material/Component |
| Action | 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.