Recall Z-0507-2013
Siemens Healthcare Diagnostics, Inc · initiated November 14, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Siemens Healthcare BR Assay for CA 27.29 250 Test Kits 03896216 50 Test Kit 02419937 Ref Kit (US only) 10340081 Intended Use The ADVIA Centaur BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur and ADVIA Centaur XP systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage Ill breast cancer.
Codes / lots: All lot codes
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: Device Design
Action taken
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.
Details
- Recall number
- Z-0507-2013
- Initiated
- November 14, 2012
- Posted by FDA
- December 11, 2012
- Terminated
- September 25, 2015
- Product code
- MOI – System, Test, Immunological, Antigen, Tumor
- Quantity
- 250 test =1678 and 50 test =2660 and Ref. 1196
- 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…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc, East Walpole, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0506-2013 Class II | Siemens Healthcare BNP (8-type Natriuretic Peptide) 500 Test kit 02816634 100 Test…Operating range of the ADVIA Centaur systems is 18C to 30C (64.4F to 86.0F), a change in room temperature… | 11/14/2012Terminated |
| Z-0508-2013 Class II | Siemens Healthcare ADVIA Centaur CA 19-9 250 Test 10491244 50 Test 10491379 Intended Use…Operating range of the ADVIA Centaur systems is 18C to 30C (64.4F to 86.0F), a change in room temperature… | 11/14/2012Terminated |
| Z-0509-2013 Class II | Siemens Healthcare ADVIA Centaur DHEA-504 (DHEAS) 50 Test 06489701 The ADVIA Centaur…Operating range of the ADVIA Centaur systems is 18C to 30C (64.4F to 86.0F), a change in room temperature… | 11/14/2012Terminated |
| Z-0510-2013 Class II | Siemens Healthcare ADVIA Centaur Digitoxin (DGTN) 250 Test 09046419 50 Test 08861968…Operating range of the ADVIA Centaur systems is 18C to 30C (64.4F to 86.0F), a change in room temperature… | 11/14/2012Terminated |
| Z-0511-2013 Class II | Siemens Healthcare ADVIA Centaur Folate (FOL) 500 Test 06891541 100 Test 06367974 Ref…Operating range of the ADVIA Centaur systems is 18C to 30C (64.4F to 86.0F), a change in room temperature… | 11/14/2012Terminated |
| Z-0512-2013 Class II | Siemens Healthcare ADVIA Centaur Theophylline 2 (THE02) 250 Test 08838753 50 Test…Operating range of the ADVIA Centaur systems is 18C to 30C (64.4F to 86.0F), a change in room temperature… | 11/14/2012Terminated |