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DATE NOTIFICATION INITIATED:
PRODUCT / MODEL NUMBER / SERIAL NUMBERS
MANUFACTURER:
Kendro Laboratory Products
Asheville, NC
REASON:
DA-12 rotor arm assemblies (P/N 04018 or P/N 04285 if in a service kit) were out of specification to their designed tolerance. The DA-12 rotor arm assembly problem prevents one or more tube holders (part number 04102) from returning to their full vertical position after completing either a high speed or low speed centrifuge run, or after completing a wash cycle. The degree of displacement was observed to be between 45 and 60 degrees. The cause of the displacement has been traced to an out of specification dimension of the tube arm located at the insertion point to the rotor disc. Consignees have been asked to contact the manufacturer to arrange for a replacement part.
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.
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