Recall Z-0508-2013 ยท NIG System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer
Siemens Healthcare Diagnostics, Inc
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 diagnos
| Date | Dec 11, 2012 (initiated Nov 14, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 co |
| Quantity | 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 I |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031393 | BAYER ADVIA CENTAUR CA 19-9 ASSAY Bayer Healthcare, LLC, Jun 24, 2003 |