Notice Information: - Advisory - 21/06/2012

Title:

ARCHITECT CA 19-9XR

Product:

ARCHITECT CA 19-9XR

Reference:

SN2012(07)

Manufacturer / Supplier:

Abbott Laboratories

Target Audience:

Hospital Risk Managers
Hospital Laboratories

Please bring this safety notice to the attention of all who need to be aware of it.

Issue:

Abbott has determined that ARCHITECT CA 19-9XR reagent lots 08849M500, 08851M500, 08852M500, 08853M500, 10122M500 and 10040M500 are demonstrating an upward shift in patient results. Abbott has advised that through their investigations, a positive median bias of 83% has been observed when compared to other ARCHITECT CA 19-9XR lots. The manufacturer advised that this issue may impact patient management when affected lots are used for monitoring patients.

Background Information / Related Documents:

The ARCHITECT CA 19-9XR assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 1116-NS-19-9 reactive determinants in human serum or plasma on the ARCHITECT i System. The ARCHITECT CA 19-9XR assay is to be used as an aid in the management of pancreatic cancer patients in conjunction with other clinical methods.

Abbott issued a field safety notice (FSN) in May 2012 advising customers to discontinue the use of ARCHITECT CA 19-9XR reagent lots 08849M500, 08851M500, 08852M500, 08853M500, 10122M500 and 10040M500 due to these lots demonstrating an upward shift in patient results. Abbott Controls do not detect the upward shift and will test within range.

The Irish Medicines Board (IMB) wish to highlight to users that although the positive median bias observed is 83%, Graph 1 in the attached field safety notice (FSN) indicates that the % bias varies between 0 - 365% over the range of the assay.

Action to be taken:

The IMB recommends that:

1. Customers consider the information in the FSN regarding the magnitude of the bias observed over the range of the assay (0-365%) and the need to review patient results.

2. Customers who determine the need to conduct a look back study and require further information in relation to this issue should contact Abbott for further advice.

A copy of the FSN is also available on the IMB website at the following link:

http://www.imb.ie/images/uploaded/documents/fsn/FSNMay2012/V14968_FSN.pdf

Further Information:

Enquiries to the manufacturer should be addressed to:

Abbott Diagnostics
Unit 4051 Kingswood Drive
Citywest Business Campus
Dublin 24

Telephone: +353 1 4691561
Mobile: +353 87 1773445
Fax: +353 1 4691565
E-mail: tara.mcgrath@abbott.com


All adverse incidents relating to a medical device should be reported to:

Human Products Monitoring Department
Irish Medicines Board
Kevin O’Malley House
Earlsfort Centre
Earlsfort Terrace
Dublin 2

Telephone: +353-1-6764971
Fax: +353-1-6344033
E-mail: vigilance@imb.ie
Website: www.imb.ie


Please click here to download a PDF version of the Safety Notice 

Please click here to dowloand a copy of the field safety notice