FDA Device recall Z-1540-2020
Dimension Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the determination of total bilirubin
- FDA Device
- Class II
- terminated
- Published 2020-04-01
On 2020-04-01 the FDA classified a Class II recall of Dimension Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the determination of total bilirubin by Siemens Healthcare Diagnostics, citing bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1540-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-02-13 |
| Published | 2020-04-01 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
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, hemolytic, hematological, and metabolic disorders, including hepatitis and gallbladder disease.
Reason
Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
Identifiers
| code_info | Lot Number/UDI: EB1008 0842768020544EB100821010810444957840 FA0365 0842768020544FA036520123010444957840 FA0346 08427…Lot Number/UDI: 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 0084276802054 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1540-2020%22
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