3500 XL DX GENETIC ANALYZER CS2
Received Mar 6, 2014 · Event occurred Feb 7, 2014
Report 3003673482-2014-00004 · MDR key 3831934
Device
Generic name
Pca
Manufacturer
Life Technologies Holdings Pte. LtdCatalog number
4461444
Lot number
25800-221
Product problems
- Failure to Calibrate
Patient
Not reported
- No Information
Narrative
Additional Manufacturer Narrative
DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INSTRUMENT WAS INVESTIGATED ON SITE. IT WAS DISCOVERED THAT THE ARRAY DOOR WAS BINDING, PREVENTING THE LASER TO PASS THROUGH CAPILLARY. THE DOOR/SPRING WAS DISASSEMBLED AND LUBRICATED. IT WAS THEN REASSEMBLED AND INSTALLED. SEVERAL SPATIAL CALIBRATIONS WERE RUN AFTER THE REPAIR AND THE INSTRUMENT PASSED REQUIRED SPECIFICATIONS. DEVICE INTENDED USE: THE APPLIED BIOSYSTEMS 3500XL DX GENETIC ANALYZER CS2 WITH 3500 DX SERIES SOFTWARE 2011 (VL) ARE INVITRO DIAGNOSTIC DEVICES INTENDED FOR THE SEQUENCING (DETECTION AND IDENTIFICATION) OF FLUORESCENTLY-LABELED DEOXYRIBONUCLEIC ACID (DNA) BY CAPILLARY ELECTROPHORESIS. THE APPLIED BIOSYSTEMS 3500XL DX GENETIC ANALYZER CS2 WITH 3500 DX SEQUENCING ASSAYS SPECIFYING THEIR USE AND ONLY BY TECHNOLOGISTS TRAINED IN LABORATORY TECHNIQUES, PROCEDURES AND USE OF THE ANALYZER.
Description of Event or Problem
A CUSTOMER REPORTED THERE WAS SPATIAL CALIBRATION FAILURE IN THE INSTRUMENT, 3500 XL DX GENETIC ANALYZER CS2 (CAT. NO. 4461444, SERIAL NO. (B)(4)). NO PATIENT INVOLVEMENT REPORTED.