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Enzymatic Method, Bilirubin
FDA product code JFM · Class 2 · Clinical Chemistry
17
Registered devices
31
Adverse events
9
Recalls
11
510(k) clearances
Devices with this code
T BIL — RANDOX LABORATORIES LIMITEDDirect Bilirubin LiquiColor® — STANBIO LABORATORY, L.P.ADVIA® Chemistry DBIL_2 Direct Bilirubin 2 Reagents — Siemens Healthcare Diagnostics Inc.Synchron — Beckman Coulter, Inc.Total Bilirubin LiquiColor® — STANBIO LABORATORY, L.P.DIRECT BILIRUBIN 2 (D BIL 2) — RANDOX LABORATORIES LIMITEDAtellica CH DBil_2 — Siemens Healthcare Diagnostics Inc.D BIL — RANDOX LABORATORIES LIMITEDSirrus® Direct Bilirubin LiquiColor® — STANBIO LABORATORY, L.P.Atellica CH TBil_2 — Siemens Healthcare Diagnostics Inc.D BIL — RANDOX LABORATORIES LIMITEDT BIL — RANDOX LABORATORIES LIMITEDTOTAL BILIRUBIN 2 (T BIL 2) — RANDOX LABORATORIES LIMITEDADVIA® Chemistry Direct Bilirubin_2 DBIL_2 Reagents — Siemens Healthcare Diagnostics Inc.Sirrus® Total Bilirubin LiquiColor® — STANBIO LABORATORY, L.P.ADVIA® Chemistry TBIL_2 Total Bilirubin_2 Reagents — Siemens Healthcare Diagnostics Inc.ADVIA® Chemistry Total Bilirubin_2 TBIL_2 Reagents — Siemens Healthcare Diagnostics Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-10-11 | Randox Laboratories Ltd. | Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin reagent (TBil) Vanadate Oxidation Method. |
| 2023-07-10 | Siemens Healthcare Diagnostics, Inc. | Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator resu |
| 2023-07-10 | Siemens Healthcare Diagnostics, Inc. | Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator resu |
| 2023-07-10 | Siemens Healthcare Diagnostics, Inc. | Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator resu |
| 2023-07-10 | Siemens Healthcare Diagnostics, Inc. | Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator resu |
| 2020-02-13 | Siemens Healthcare Diagnostics, Inc. | Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy |
| 2020-02-13 | Siemens Healthcare Diagnostics, Inc. | Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy |
| 2020-02-13 | Siemens Healthcare Diagnostics, Inc. | Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy |
| 2020-02-13 | Siemens Healthcare Diagnostics, Inc. | Bilirubin assays may exhibit a positive bias with patients on eltrombopag therapy |
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