Date Initiated by Firm | November 14, 2012 |
Date Posted | December 11, 2012 |
Recall Status1 |
Terminated 3 on September 25, 2015 |
Recall Number | Z-0508-2013 |
Recall Event ID |
63682 |
510(K)Number | K031393 |
Product Classification |
System, test, carbohydrate antigen (ca19-9), for monitoring and management of pancreatic cancer - Product Code NIG
|
Product | Siemens Healthcare ADVIA Centaur CA 19-9
250 Test 10491244
50 Test 10491379
Intended Use The ADVIA Centaur CA 19-9 Assay is an in vitro immunoassay for the quantitative measurement of the CA 19-9 tumor-associated antigen, in human serum, using the ADVIA Centaur and ADVIA Centaur XP systems. This assay is indicated for the serial measurement of CA 19-9 to aid in the management of patients diagnosed with cancers of the exocrine pancreas. |
Code Information |
All lot codes |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics, Inc 333 Coney St East Walpole MA 02032-1516
|
For Additional Information Contact | 508-668-5000 |
Manufacturer Reason for Recall | Operating range of the ADVIA Centaur systems is 18C to 30C (64.4F to 86.0F), a change in room temperature may increase or decrease assay results, depending on the specific assay and ADVIA Centaur system used. |
FDA Determined Cause 2 | Device Design |
Action | Siemens Healthcare issued An Urgent Medical Device Correction Notice (for US customers) and an Urgent Field Safety Notice (for customers outside the US) dated November 5, 2012, to all affected customers. These notices inform customers who used the ADVIA Centaur BNP, BR, CA 19-9, Digitoxin, Folate, and Theophylline 2 assays to reduce their instrument operating temperature
range to 20 -25 degrees C and for the DHEAS assay to reduce the
instrument operating temperature range to 18 -26 degrees C when these
assays are being used. These notices also direct customers to review the
contents of the correction notice with their Laboratory Director or Medical
Director. A confirmation fax-back form was included to ensure that all
customers worldwide have been notified and have complied with the
mandatory action.
Customers with questions were instructed to contact their Siemens Technical Solutions Center or their local technical support representative.
For questions regarding this recall call 508-668-5000. |
Quantity in Commerce | 250 test=525 and 50 test=12243 |
Distribution | Worldwide Distribution - USA (nationwide) and Internationally to the following countries:
Argentina
Australia
Austria
Azerbaijan
Belgium
Bosnia Herzeg.
Brazil
Canada
Chile
COLOMBIA
Croatia
Czech Republic
Denmark
Egypt
Estonia
Finland
France
Germany
Greece
Hong Kong
Hungary
Iceland
India
Indonesia
Iran
Ireland
Italy
Japan
Kazakhstan
Latvia
Lithuania
Malaysia
Mexico
Netherlands
New Caledonia
Norway
Oman
P.R. China
Philippines
Poland
Portugal
Qatar
Rep. of Yemen
Republic Korea
Reunion
Romania
Russian Fed.
Saudi Arabia
Serbia
Slovakia
Slovenia
South Africa
Spain
Sweden
Switzerland
Taiwan
Thailand
Turkey
U.A.E.
United Kingdom
Uruguay
Vietnam |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database | 510(K)s with Product Code = NIG
|