Recall Z-1541-2020
Siemens Healthcare Diagnostics, Inc. · initiated February 13, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Dimension Vista Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the determination of total bilirubin. SMN: 10445146 Product Usage: Dimension Vista TBIL method is an in vitro diagnostic test intended to quantitatively measure total bilirubin in human serum and plasma on the Dimension Vista System. Measurements of total bilirubin are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gallbladder disease.
Codes / lots: Lot Number/UDI: Lot # UDI Number EB1008 0842768020544EB100821010810444957840 FA0365 0842768020544FA036520123010444957840 FA0346 0842768020544FA034620121110444957840 GB0326 00842768020544GB032620112110444957840 EA0318 00842768020544EA031820111310444957840 GD0309 00842768020544GD030920110410444957840 FB0298 00842768020544FB029820102410444957840 GA0284 00842768020544GA028420101010444957840 GB0275 00842768020544GB027520100110444957840 GD0274 00842768020544GD027420093010444957840 FB0263 00842768020544FB026320091910444957840 GA0256 00842768020544GA025620091210444957840 GB0242 00842768020544GB024220082910444957840 FD0226 00842768020544FD022620081310444957840 EB0221 00842768020544EB022120080810444957840 EB0192 00842768020544EB019220071010444957840 ED0191 00842768020544ED019120070910444957840 FC0170 00842768020544FC017020061810444957840 FA0169 00842768020544FA016920061710444957840 GA0157 00842768020544GA015720060510444957840 BB0134 00842768020544BB013420051310444957840 GB0122 00842768020544GB012220050110444957840 GA0121 00842768020544GA012120043010444957840 GD0113 00842768020544GD011320042210444957840 GD0093 00842768020544GD009320040210444957840 GD0086…
Reason for recall
Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
FDA-determined cause: Under Investigation by firm
Action taken
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 bilirubin assay is not recommended for patients on eltrombopag therapy (Dimension and Dimension Vista). Review the letter with their Medical Director Complete and return the Field Correction Effectiveness Check Form attached to the letter within 30 days. If they have received any complaints of illness or adverse events associated with the product, immediately contact their local Siemens Customer Care Center or their local Siemens Technical Support Representative.
Details
- Recall number
- Z-1541-2020
- Initiated
- February 13, 2020
- Terminated
- April 23, 2021
- Product code
- CIG – Diazo Colorimetry, Bilirubin
- 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, United Kingdom, Afghanistan, Albania, Algeria, Angola, Argentina, Armenia, Australia, Azerbaijan…
- Recalling firm
- Siemens Healthcare Diagnostics, Inc., Newark, DE
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1536-2020 Class II | Atellica CH Direct Bilirubin_2 assay In vitro Diagnostic for the determination of direct…Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy | 02/13/2020Terminated |
| Z-1537-2020 Class II | Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination of total…Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy | 02/13/2020Terminated |
| Z-1538-2020 Class II | ADVIA Chemistry Direct Bilirubin_2 assay-SMN: 10316610 (20 mL) & 10341114 (70 mL) -…Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy | 02/13/2020Terminated |
| Z-1539-2020 Class II | ADVIA Chemistry Total Bilirubin_2 assay- SMN: 10341115 (40 mL) & 10341113 (70 mL).…Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy | 02/13/2020Terminated |
| Z-1540-2020 Class II | Dimension Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the…Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy | 02/13/2020Terminated |