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Bromcresol Green Dye-Binding, Albumin
FDA product code CIX · Class 2 · Clinical Chemistry
86
Registered devices
117
Adverse events
6
Recalls
120
510(k) clearances
Devices with this code
Teco Diagnostics TC Matrix Clinical Chemistry Analyzer — TECO DIAGNOSTICSPointe Albumin Reagent — HORIBA INSTRUMENTS INCORPORATEDABX PENTRA ALBUMIN CP — HORIBA ABX SASAlbumin Reagent Set — TECO DIAGNOSTICSAlbumin / BS480 — Medtest Dx, Inc.POINTE SCIENTIFIC ALBUMIN — HORIBA INSTRUMENTS INCORPORATEDPOINTE SCIENTIFIC Albumin Standard — HORIBA INSTRUMENTS INCORPORATEDJAS Diagnostics — DREW SCIENTIFIC, INC.SPOTCHEM™ II Albumin — ARKRAY USA, INC.AU — Beckman Coulter, Inc.Albumin Std (w/ssa#) — HORIBA INSTRUMENTS INCORPORATEDARCHITECT — ABBOTT IRELANDIDG/Sanzay — IDG/SANZAY CorporationTeco Diagnostics TC Matrix Clinical Chemistry Analyzer — TECO DIAGNOSTICSYumizen C1200 Albumin — HORIBA ABX SASAlbumin Gen2 — Roche Diagnostics GmbHALB — RANDOX LABORATORIES LIMITEDPointe Scientific, Inc. Albumin — HORIBA INSTRUMENTS INCORPORATEDAlbumin (w/ssa#) — HORIBA INSTRUMENTS INCORPORATEDAlbumin / BS200 — Medtest Dx, Inc.ALBUMIN Assay — Sekisui Diagnostics, LLCSynermed® — INFRARED LABORATORY SYSTEMS LLCAlbumin Gen2 — Roche Diagnostics GmbHTeco Diagnostics TC Matrix Clinical Chemistry Analyzer — TECO DIAGNOSTICS
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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