Notice type: Advisory

Date: 21/06/2012


Product name or type:


Manufacturer Or 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.

Problem Or 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 Or 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.

ARCHITECT CA 19-9XR Document

Actions 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 HPRA website at the following link: 

Urgent Field Safety Notice - V14968

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 

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

Human Products Monitoring Department 
Health Products Regulatory Authority
Kevin O’Malley House 
Earlsfort Centre 
Earlsfort Terrace 
Dublin 2 

Telephone: +353-1-6764971 
Fax: +353-1-6344033 

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

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

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