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October 16, 2008

URGENT: PRODUCT CORRECTIVE ACTION


UniCel® DxI® 800 and UniCel DxI 600 Access® Immunoassay Systems
and UniCel DxC 880i SYNCHRON® Access Clinical System
Peristaltic Pump Mfg. Nos. A62712, A62839, A62840, A62841, and A63124

Dear Beckman Coulter UniCel Customer:

We have confirmed reports of a new premature failure of the upper aspirate peristaltic pump in the
systems listed above. Premature failure of the pump may negatively affect precision. The failure
is limited to those UniCel DxI 800, DxI 600, and DxC 880i systems which have a pump identified with
one of the new pump manufacturing numbers (Mfg. Nos.) listed above. Our records indicate that
you have an instrument with one of these pumps.

The upper peristaltic pump assembly may not maintain a proper flow rate. We are investigating
potential solutions to this failure. We will contact you to arrange a date to service the affected pumps
as soon as possible. Please take the actions listed below until this service occurs.

1. Verify that each serial number listed on the enclosed Response form matches a serial number
on a DxI instrument in your lab. To view the instrument serial number, select Configure F8
from the Main Menu, and then select System Setup F1. If you have a serial number that is not
listed, that instrument does not have an affected pump and you do not need to complete step
2.
2. For instruments with matching serial numbers, please run the washed portion of the system
check routine every 24 hours, as part of daily maintenance, until the pumps are serviced.
Instructions are in the attached Daily Washed System Check information update.
• If the washed routine results are as expected, continue daily processing.
• If the washed routine results are not as expected, follow the troubleshooting instructions
in the attached procedures.

Please share this information with your laboratory staff and retain this letter for your Quality System
documentation. Whether or not you have an affected pump, please complete and return the enclosed
Response form within 10 days so we can be assured that you have received this important
notification.

If you have any questions regarding this notification, please contact your local Beckman Coulter
representative. We sincerely apologise for any inconvenience that this may have caused your
laboratory. Thank you for your continued support of Beckman Coulter products.

Sincerely,

Dave King
Quality / Regulatory Affairs Northern Region Europe
Tel 01494 429184/01494 429189
Fax 01494 429182

Enclosures (2): System Check Instruction, Response Form

PCA-C-F-1052 Page 1 of 3
Daily Washed System Check

UniCel® DxI® Access® Immunoassay System


Information Update
September 2008

Daily Washed System Check

Add this procedure to your DxI daily maintenance procedures until further notice. Follow this procedure to run the
daily washed system check, and review and troubleshoot results as indicated in this information update (IU).
Contact Technical Support if you have questions or need assistance.

Running the Washed System Check Routine


Daily, use this procedure to run a maintenance request for the washed system check routine with System Check
Solution (part number 81910). After you prepare and load the rack, the request takes about 15 minutes to complete.

System Mode: Ready

1. From the Sample Manager screen , select New Request F2, and then select Maintenance F3 to display the
Request Maintenance window.

2. From the System Check Routines options, select Washed and then OK F1.

3. Enter the rack ID and press [Enter].

4. Place 4 mL of 100% System Check Solution into a 13 x 100 mm sample container in position 1 of a
13 x 100 mm rack. Leave positions 2 through 4 empty.

5. Load the sample rack.

6. Review the results on the System Check Data screen. From the Main Menu, select Maintenance Review F6,
then System Check F2. Select any point from the current run and then select System Check Data F2.

7. Compare the results with the expected results.

Washed Routine
Expected Mean RLUs Expected %CV Results
5,000 to 20,000 ≤ 12.00

• If the mean and %CV are as expected, continue with your daily processing.

© 2008 Beckman Coulter, Inc.


P/N A66058A 9/08 Page 2 of 3
PCA-C-F-1052
UniCel DxI Systems Daily Washed System Check

• If the mean or %CV are not as expected, follow the Washed System Check Troubleshooting Instructions in
this document.

• If after troubleshooting, the results are still not as expected, contact Customer Technical Support.

Washed System Check Troubleshooting Instructions


Use this procedure to troubleshoot washed system check results that did not meet expected values.
System Mode: Ready Not Ready

1. Inspect the upper aspirate probe pump for leakage, according the instructions in this document. If you find
leakage, contact Customer Technical Support immediately.

2. If you see no evidence of leakage at the pump, install clean aspirate probes and replace the duck bill valve. For
more information, consult the "Replacing the Duck Bill Valve" and the "Installing Clean Aspirate Probes"
procedures in the Maintenance chapter of the UniCel DxI Instructions for Use.

3. Run the washed system check routine again, according to instructions in this document.

4. If after troubleshooting the results are still not as expected, contact Customer Technical Support.

Contact
If you have any questions about this information, contact Beckman Coulter. Please be prepared to provide your
system ID.
• In the U.S.A. or Canada, contact Technical Support at 800-854-3633 or online at
www.beckman.com/customersupport. Before using online support the first time, you will need to register
online.
• Outside the U.S.A. and Canada, contact your technical support representative.

Access, Unicel, DxI, and the Beckman Coulter logo are trademarks of Beckman Coulter, Inc.

© 2008 Beckman Coulter, Inc.


P/N A66058A 9/08 Page 3 of 3
PCA-C-F-1052
BECKMAN COULTER United Kingdom Ltd

QUALITY SYSTEM – FORM

VIGILANCE RESPONSE FORM


Please complete the appropriate sections below:

Site Name: ________________________________

Instrument Type: ________________________________

Serial Number(s): ________________________________

URGENT: PRODUCT CORRECTIVE ACTION


UniCel® DxI® 800 and UniCel DxI 600 Access® Immunoassay Systems
and UniCel DxC 880i SYNCHRON® Access Clinical System
Peristaltic Pump Mfg. Nos. A62712, A62839, A62840, A62841, and A63124

□ The Notification has been actioned – I have read and understood the information within
the accompanying Beckman Coulter Notification. All relevant personnel have been
informed of its contents, any recommended actions taken and records retained as part
of our Laboratory Quality System documentation.
For Kit related Notifications only:
Number of Kits Number of Kits Number of Kits returned
already used discarded to Beckman Coulter

or:
□ The Notification has not been actioned – I do not understand the Beckman Coulter
Notification and require further assistance.
or:
□ The Notification has not been actioned – We do not have this product.

Signed: ________________________ Date: ___________________________

Name: ________________________ Tel: ___________________________


(Please Print):

Email: ______________________________________________________________

Please return this form by fax, post or email to:

Claire Burke / Sue Fowler Fax no: 01494 429182


Beckman Coulter UK Ltd Tel no: 01494 429189 / 01494 429184
Oakley Court Email: ukqualityadmin@beckmancoulter.com
Kingsmead Business Park
London Road, High Wycombe
BUCKS, HP11 1JU

FSN Number: 1052

Document Number: BCUK-REG-F05 Revision Number: 3


Printed on: 29-Oct-08 Note: Printed copies are uncontrolled.
Updates: To modify or update this document contact the Quality Department