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Bromcresol Purple Dye-Binding, Albumin
FDA product code CJW · Class 2 · Clinical Chemistry
30
Registered devices
17
Adverse events
1
Recalls
18
510(k) clearances
Devices with this code
Piccolo General Chemistry 13 — ABAXIS, INC.Albumin BCP (6x20 mL) — SENTINEL CH. SPASynchron — Beckman Coulter, Inc.ARCHITECT — ABBOTT IRELANDAlbumin BCP — Roche Diagnostics GmbHADVIA® Chemistry Albumin BCP Reagents — Siemens Healthcare Diagnostics Inc.Atellica CH AlbP — Siemens Healthcare Diagnostics Inc.Alinity — Abbott GmbHAlinity — ABBOTT IRELANDPiccolo AmLyte 13 — ABAXIS, INC.Alinity — ABBOTT IRELANDGENCHEM™ Albumin Reagent — GENCHEM INCCAROLINA LIQUID CHEMISTRIES CORP.® ALB RGT.KIT AU-214 — CAROLINA LIQUID CHEMISTRIES CORPORATIONARCHITECT — ABBOTT LABORATORIESPiccolo MetLac 12 Panel — ABAXIS, INC.Dimension Vista® Flex® reagent cartridge ALB — Siemens Healthcare Diagnostics Inc.Piccolo Renal Function Panel — ABAXIS, INC.Piccolo Hepatic Function Panel — ABAXIS, INC.Piccolo BioChemistry Panel Plus — ABAXIS, INC.Synchron — Beckman Coulter, Inc.ARCHITECT — ABBOTT IRELANDCAROLINA LIQUID CHEMISTRIES CORP.™ ALB ALBUMIN REAGENT CC214 — CAROLINA LIQUID CHEMISTRIES CORPORATIONAlbumin BCP (6x50 mL) — SENTINEL CH. SPAADVIA® Chemistry Albumin BCP Reagents — Siemens Healthcare Diagnostics Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-03-18 | Roche Diagnostics Corporation | The reagent lot is exhibiting calibration failures, QC imprecision, and elevated QC recovery due to elevated pH level causing higher absorbance values. |
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