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Bromcresol Green Dye-Binding, Albumin
FDA product code CIX · Class 2 · Clinical Chemistry
86
Registered devices
113
Adverse events
6
Recalls
120
510(k) clearances
Devices with this code
Atellica CH Alb — Siemens Healthcare Diagnostics Inc.Pointe Albumin on BS480 Analyzer — HORIBA INSTRUMENTS INCORPORATEDSPOTCHEM™ II Total Bilirubin — ARKRAY USA, INC.Albumin Reagent Set — TECO DIAGNOSTICSTeco Diagnostics TC Matrix Clinical Chemistry Analyzer — TECO DIAGNOSTICSVITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.Albumin Gen2 — Roche Diagnostics GmbHARCHITECT — ABBOTT LABORATORIESAlinity — ABBOTT IRELANDSynermed® — INFRARED LABORATORY SYSTEMS LLCALBUMIN Assay — SEKISUI DIAGNOSTICS, LLCALB — RANDOX LABORATORIES LIMITEDVITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.Albumin (w/ssa#) — HORIBA INSTRUMENTS INCORPORATEDARCHITECT — ABBOTT IRELANDYumizen C1200 Albumin — HORIBA ABX SASAU — Beckman Coulter, Inc.JAS Diagnostics — DREW SCIENTIFIC, INC.POINTE SCIENTIFIC ALBUMIN — HORIBA INSTRUMENTS INCORPORATEDAlbumin -BCG method TC-Matrix — TECO DIAGNOSTICSJAS Diagnostics — DREW SCIENTIFIC, INC.ARCHITECT — Abbott GmbHSynermed® — INFRARED LABORATORY SYSTEMS LLCAlbumin Gen.2 — Roche Diagnostics GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-07-10 | Ortho-Clinical Diagnostics, Inc. | The reason for this recall is QuidelOrtho has determined that during normal use the VITROS XT ALB-TP Slides may shed dust and debris as they travel through the |
| 2020-08-27 | Roche Diagnostics Operations, Inc. | Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the identified products. A discoloration (yellow color) was ob |
| 2019-09-11 | Roche Diagnostics Operations, Inc. | Due to low Quality Control recovery and invalid Calibration. |
| 2013-06-12 | Ortho-Clinical Diagnostics | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. |
| 2010-03-10 | Abbott Laboratories Inc. | Observed particulate matter in some reagent cartridges. |
| 2008-06-11 | Roche Diagnostics Corp. | Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader. |
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