Recall Z-2660-2016
Tecan US, Inc. · initiated July 25, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Infinite F50 instrument. The INFINITE F50 instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to obtain information on physiological and pathological states. For applications in human clinical diagnostic uses, only the Magellan Tracker software is intended for the use with the instrument. Software and instrument have been validated for measurement and for the evaluation of qualitative and quantitative Enzyme-linked Immunosorbent Assays (ELISA) according to the scheduled diagnostic parameters and instrument specifications; they are therefore for professional use in in-vitro diagnostics
Codes / lots: Instrument Material #330087508, PC Serial # CND5219H07, Instrument Serial #1508007738.
Reason for recall
The batteries have the potential to overheating, melt or char.
FDA-determined 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.
Details
- Recall number
- Z-2660-2016
- Initiated
- July 25, 2016
- Posted by FDA
- August 25, 2016
- Terminated
- January 23, 2017
- Product code
- JJQ – Colorimeter, Photometer, Spectrophotometer For Clinical Use
- 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.
- Recalling firm
- Tecan US, Inc., Morrisville, NC
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2661-2016 Class II | SUNRISE instrument. The INFINITE F50 instrument is a 96-well absorbance reader for the…The batteries have the potential to overheating, melt or char. | 07/25/2016Terminated |
| Z-2662-2016 Class II | Tecan Infinite 200. The SUNRISE instrument is a 96-well absorbance reader for the…The batteries have the potential to overheating, melt or char. | 07/25/2016Terminated |
| Z-2663-2016 Class II | Infinite 200 PRO The Tecan Infinite 200 PRO is a multifunctional microplate reader with…The batteries have the potential to overheating, melt or char. | 07/25/2016Terminated |
| Z-2664-2016 Class II | Tecan Infinite M1000 The Tecan Infinite M1000 is a multifunctional monochromator based…The batteries have the potential to overheating, melt or char. | 07/25/2016Terminated |
| Z-2665-2016 Class II | Tecan Infinite M1000 PRO The Tecan Infinite M1000 PRO is a multifunctional…The batteries have the potential to overheating, melt or char. | 07/25/2016Terminated |
| Z-2666-2016 Class II | Hydroflex ELISA The HYDROFLEX is a plate washer for 96-well microplates. The instrument…The batteries have the potential to overheating, melt or char. | 07/25/2016Terminated |