Hi James!
We have heard this complaint from other FACSCalibur customers, which has prompted us to develop a more reliable alternative. We are in the final testing stages for a red diode alternative for FACScaliburs and hope to be able to release it shortly. I will be glad to provide you with more detailed information once the product is released. We have heard from some customers that BD has told them that they can not use our parts in their instruments because they are not "FDA" approved. We have contacted the FDA on this issue and their response was that they consider this a "replacement part" and as long as it meets original OEM specifications and performs in the same manner as the original part it does not require us to get "FDA approval". The onus is on the original manufacturer to get FDA approval. The following is excerpted from the FDA's response:
"The distinction is between refurbisher and remanufacturer. As long as
Tritech does not: (1) make claims that go beyond BD's original medical claims for their products (such as "it now processes twice the number of blood samples per hr") or (2) change the specs of the product (significantly higher accessible laser output level, different wavelength, safety features or labels now removed or defeated, etc), then your "service" is service by our definition and not considered an act of remanufacturing. Therefore, you are not required to do anything for us."
If you need any additional information, please feel free to contact Ray Lannigan (lannigan@tritechinc.com) or myself.
Regards,
Joanne Thomas, M.S.
Director of Operations
TRITECH Field Engineering
2014 Renard Court, Suite I
Annapolis, MD 21401
1-800-886-7004 (USA)
1-410-266-1522
410-266-0935 (FAX)
thomas@tritechinc.com
-----Original Message-----
From: James F. George, Ph.D. <jgeorge@uab.edu>
To: Cytometry Mailing List <cytometry@flowcyt.cyto.purdue.edu>
Date: Tuesday, December 18, 2001 9:05 PM
Subject: FACSCalibur Red Diode Laser Reliability
Greetings fellow flow cytometrists
We recently acquired a new dual laser facscalibur. We have had some serious problems with the stability of the red diode laser. In two months, the laser has been changed out three times and our fourth service call for the same problem will commence tomorrow. Typically, one will observe a decline in sensitivity in fluorescence in channels that rely on the use of the diode laser, accompanied by a large increase in the amount of compensation required for those same fluorescence channels (I am being deliberately non-specific here to accomodate those who do not have BD instruments, for those facscalibur users, I am obviously talking about FL4, but this would depend on the fluorochromes that were being used etc). I went with BD because my previous long experience with the highly reliable Facsscan and the fact that I really needed two lasers. Unfortunately, the other laser is not useful if it is unreliable.
Have others experienced this problem, particularly since BD switched suppliers for the diode laser?
This is making me crazy. Any info you have on this would be useful. I am working with BD on this (upper management has been pretty responsive), but currently I have not seen a permanent solution to the problem.
-James
This archive was generated by hypermail 2b29 : Wed Apr 03 2002 - 11:58:08 EST