Recall Z-1537-2020 ยท JFM Enzymatic Method, Bilirubin
Siemens Healthcare Diagnostics, Inc.
Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination of total bilirubin SMN: 11097531 - Product Usage: Atellica TBil_2 assay is for in vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma (lithium heparin) of adults and neonates using the Atellica CH Analyzer. Measurement of total bilirubin, an organic compound formed during
| 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 | 2323 US and 8193 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
| K053131 | WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191 Wako Chemicals USA, Inc., Dec 30, 2005 |