FDA Device recall Z-1536-2020
Atellica CH Direct Bilirubin_2 assay In vitro Diagnostic for the determination of direct bilirubin SMN: 11097532 - Product Usage: ADVIA DBI…
- FDA Device
- Class II
- terminated
- Published 2020-04-01
On 2020-04-01 the FDA classified a Class II recall of Atellica CH Direct Bilirubin_2 assay In vitro Diagnostic for the determination of direct bilirubin SMN: 11097532 - Product Usage: ADVIA DBI… 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-1536-2020 |
| 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
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.
Reason
Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
Identifiers
| code_info | Lot # UDI Number 190273 (01)00630414595801(10)190273(17)20201203 190187 (01)006304145…Lot # UDI Number 190273 (01)00630414595801(10)190273(17)20201203 190187 (01)00630414595801(10)190187(17)200820 190120 (01)00630414595801(10)190120(17)200521 |
|---|
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-1536-2020%22
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