CJWClass II

Bromcresol Purple Dye-binding, Albumin

Clinical Chemistry · 21 CFR 862.1035

MDR events17All time

Recalls1All time

Registered firms40Currently listed

510(k) clearances18All time

Recent MDR events

17 adverse event reports on file

Event type breakdown

Malfunction16

Other1

Most-reported manufacturers

Roche Diagnostics8 Siemens Healthcare Diagnostics Inc5 Abbott Manufacturing, Inc1 Abbott Manufacturing, Inc.1 Siemens Healthcare Diagnostics Inc.1 Siemens Healthcare Diagnostics, Inc.1

Recalls

1 recall events for this product code

Roche Diagnostics Corporation
TerminatedUnknown
Albumin BCP
The reagent lot is exhibiting calibration failures, QC imprecision, and elevated QC recovery due to elevated pH level causing higher absorbance values.
Z-1194-2019 · View FDA record ↗

Registered firms

40 firms currently registered for this product code

510(k) clearances

18 clearances for this product code