Vaccines, Blood & Biologics

Urgent Field Safety Notice (10699578) OpenGene DNA Sequencing System MicroCel 500 and MicroCel 300 Buffer Chamber Possible Hazard

DATE NOTICE INITIATED: March 2013

PRODUCT / LOT NUMBER

MicroCel 500 buffer chamber
Part Number 10312319/VG 42115
Manufacture Date Code Range: Dec-03-09-xx to Aug-02-10-xx

MicroCel 300 buffer chamber
Part Number 10319937/ VG 42044
Manufacture Date Code Range: Feb-02-10-xx to Jul-07-10-xx

MANUFACTURER:

Siemens Healthcare Diagnostics, Inc.
Berkeley, CA

REASON:

Siemens Healthcare Diagnostics is conducting a voluntary corrective action for the buffer chambers listed above. Some of these buffer chambers may have the potential to leak buffer when in use. If the buffer chamber leaks, it could cause premature failure with heat damage to the buffer chamber and Long-Read Tower and pose a hazard to the operator. Customers are asked to follow the instructions in the Urgent Field Safety Notice.


The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.

Page Last Updated: 08/20/2014
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