Recall Z-1536-2020 ยท JFM Enzymatic Method, Bilirubin
Siemens Healthcare Diagnostics, Inc.
Atellica CH Direct Bilirubin_2 assay In vitro Diagnostic for the determination of direct bilirubin SMN: 11097532 - Product Usage: ADVIA DBIL_ 2 is for in vitro diagnostic use in the quantitative determination of direct bilirubin in human serum and plasma on the ADVIA Chemistry systems. Such measurements are useful in the screening of liver function disorders or in the diagnosis of jaundice.
| 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 | 577 US and OUS 2617 |
| 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
| K053132 | WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-23791 Wako Chemicals USA, Inc., Dec 30, 2005 |