Recall Z-1540-2020 ยท CIG Diazo Colorimetry, Bilirubin
Siemens Healthcare Diagnostics, Inc.
Dimension Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the determination of total bilirubin. SMN: 10444957 Product Usage: Dimension TBI method for the clinical chemistry syst6em is an in vitro diagnostic test intended to quantitatively measure total bilirubin in human serum and plasma. Dimension Measurements of total bilirubin are used in the diagnosis and treatment of liver
| Date | Feb 13, 2020 |
| Status | Terminated |
| Reason | Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy |
| Root cause | Under Investigation by firm |
| Action | Siemens Healthineers issued Urgent Medical Device Correction (UMDC # ACHC-20-02.A.US, ACHC-20-02.A.US.AC, ACHC-20-02.A.US.DM, ACHC-20-02.A.US.DV) and Urgent Field Safety Notice (UFSN # ACHC-20-02.A.OUS, ACHC-20-02.A.OUS.AC, ACHC-20-02.A.OUS.DM, ACHC-20-02.A.OUS.DV) on February 13, 2020 to all Atellica CH, ADVIA CH, Dimension, and Dimension Vista customers to inform them of the issue, the potential risk to health, and actions to be taken by the customer. Customers were instructed to:Review the information on eltrombopag interference (ADVIA CH and Atellica CH bilirubins) or use of total bilir |
| Quantity | 1639 US and 747 OUS |
| Distribution | Nationwide Foreign: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, Un |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060628 | DIMENSION TBI FLEX AND DBI FLEX REAGENT CARTRIDGES AND TBI/DBI CALIBRATOR Dade Behring, Inc., Apr 6, 2006 |