APPLIED BIOSYSTEMS 7500 FAST DX REAL TIME PCR
Received Jun 27, 2014 · Event occurred May 22, 2013
Report 3003673482-2014-00029 · MDR key 3978839
Device
Generic name
Instrumentation For Clinical
Manufacturer
Life Technologies Holdings Pte. Ltd.Catalog number
4407205
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. REPAIR COMPLETED BY RE-ALIGNING HEATER COVER. THIS DEVICE IS USED TO OBTAIN RESULTS FOR A DIAGNOSIS. DEVICE INTENDED USE: THE APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH THE SDS SOFTWARE VERSION 1.4 IS AN REAL-TIME NUCLEIC ACID AMPLIFICATION AND DETECTION SYSTEM THAT MEASURES NUCLEIC ACID SIGNALS FROM REVERSE TRANSCRIBED RNA AND CONVERTS THEM TO COMPARATIVE QUANTITATIVE READOUTS USING FLUORESCENT DETECTION OF DUAL-LABELED HYDROLYSIS PROBES. THE 7500 FAST DX REAL-TIME PCR INSTRUMENT IS TO BE USED ONLY BY TECHNOLOGISTS TRAINED IN LABORATORY TECHNIQUES, PROCEDURES, AND ON USE OF THE ANALYZER.
Description of Event or Problem
A CUSTOMER REPORTED A MISALIGNED HEATER COVER ON THE INSTRUMENT APPLIED BIOSYSTEMS 7500 FAST DX (CT. NO. 4407205) WITH SERIAL NO. (B)(4), RESULTING IN INCORRECT REPORTING RESULTS. NO PT INVOLVEMENT REPORTED. (B)(4).