Atellica CH DBil_2 11097532Recalls & reported problems
Siemens Healthcare Diagnostics Inc. · Direct Bilirubin (Dbil_2) Atellica CH - RGT 1792T · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier.
1 other recall cover devices cleared under the same FDA submission (K053132); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Feb 13, 2020Class IITerminated
Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy
Z-1536-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K053132. One submission often covers many models, so check the product and lot details in each record.
- Z-1538-2020 · Feb 13, 2020 · TerminatedADVIA Chemistry Direct Bilirubin_2 assay-SMN: 10316610 (20 mL) & 10341114 (70 mL) - Product Usage: ADVIA DBIL_ 2 is for in vitro diagnostic use in the quantitative determination o
Other ENZYMATIC METHOD, BILIRUBIN devices
- Atellica CH TBil_2 11097531Siemens Healthcare Diagnostics Inc. · ENZYMATIC METHOD, BILIRUBIN2 recalls3 reports
- ADVIA® Chemistry DBIL_2 Direct Bilirubin 2 Reagents 10316610Siemens Healthcare Diagnostics Inc. · ENZYMATIC METHOD, BILIRUBIN1 recall0 reports
- ADVIA® Chemistry Direct Bilirubin_2 DBIL_2 Reagents 10341114Siemens Healthcare Diagnostics Inc. · ENZYMATIC METHOD, BILIRUBIN1 recall0 reports
- ADVIA® Chemistry TBIL_2 Total Bilirubin_2 Reagents 10341115Siemens Healthcare Diagnostics Inc. · ENZYMATIC METHOD, BILIRUBIN1 recall0 reports
- TOTAL BILIRUBIN 2 (T BIL 2) BR8377Randox Laboratories Limited · Enzymatic Method, Bilirubin1 recall0 reports
- T BIL BR9766Randox Laboratories Limited · Enzymatic Method, Bilirubin1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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