T BIL BR9766Recalls & reported problems
Randox Laboratories Limited · The device is intended for the quantitative in vitro determination of total bilirubin in serum or plasma. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- 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 still open.
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. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Oct 11, 2023Open, Classified
Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin reagent (TBil) Vanadate Oxidation Method.
Z-0501-2024 · Root cause: Device Design · FDA record ↗
Other Enzymatic Method, Bilirubin devices
- Atellica CH TBil_2 11097531Siemens Healthcare Diagnostics Inc. · ENZYMATIC METHOD, BILIRUBIN2 recalls3 reports
- Atellica CH DBil_2 11097532Siemens 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
- 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
- TOTAL BILIRUBIN 2 (T BIL 2) BR8377Randox 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 13, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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