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Notice of Field Correction: Sorvall Cellwasher 2, Cell Washing System-Kendro Laboratory Products

DATE NOTIFICATION INITIATED:

 

February 18, 2005

 

PRODUCT / MODEL NUMBER / SERIAL NUMBERS

 

Sorvall Cellwasher 2 containing a (DA-12 rotor arm assembly)
Model Number: 04500
Serial Numbers: 

 

R28O-155736-SO
S11O-155794-SO
S11O-155795-SO
S17O-155835-SO
S24O-155869-SO
S24O-155870-SO
T07O-155911-TO
T14O-155953-TO 

T14O-155954-TO
U12O-156092-UO
U19O-156114-UO
U19O-156115-UO
U26O-156156-UO
U26O-156157-UO
V03O-156216-VO
V03O-156218-VO 

V09O-156247-VO
V09O-156253-VO
V09O-156254-VO
V09O-156261-VO
V09O-156262-VO
V09O-156263-VO
V09O-156264-VO
V09O-156265-VO 

V09O-156266-VO
V16O-156330-VO
W140-156453-WO
W14O-156447-WO
W14O-156451-WO
W23O-156496-WO
W23O-156506-WO
X14N-109222-XN

 

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.

 

 

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002