VERTI DX THERMAL CYCLER
Received May 2, 2014 · Event occurred Mar 3, 2014
Report 3003673482-2014-00010 · MDR key 3949765
Device
Generic name
Thermocycler, Generic
Manufacturer
Life Technologies Holdings Pte. Ltd.Catalog number
4452300
Product problems
- Device Displays Incorrect Message
- Device Operates Differently Than Expected
Patient
Not reported
- No Information
Narrative
Additional Manufacturer Narrative
DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INSTRUMENT WAS RETURNED TO LIFE TECHNOLOGIES CORPORATION AND REPAIRED BY REPLACING THE POWER AMP BOARD. AFTER REPAIR THE UNIT WAS TESTED AND PASSED PERFORMANCE SPECIFICATIONS. DEVICE INTENDED USE: THE APPLIED BIOSYSTEMS VERITI DX THERMAL CYCLER AMPLIFIES HUMAN NUCLEIC ACID SAMPLES FOR DIAGNOSTIC APPLICATIONS. THE VERITI DX THERMAL CYCLER IS TO BE USED ONLY BY OPERATORS TRAINED IN LABORATORY TECHNIQUES AND PROCEDURES.
Description of Event or Problem
A CUSTOMER REPORTED AN ERROR MESSAGE "ERROR 0X8007" COMING FROM THE INSTRUMENT, VERITI DX THERMAL CYCLER (CAT NO. 4452300, SERIAL NO. (B)(4)). NO PATIENT INVOLVEMENT REPORTED. THE COMPANY EVENT TRACKING NO. IS (B)(4).
Remedial action
- Repair