KSGClass II

Media, Potentiating For In Vitro Diagnostic Use

Hematology · 21 CFR 864.9600

MDR events11All time

Recalls1All time

Registered firms35Currently listed

510(k) clearances13All time

Recent MDR events

11 adverse event reports on file

Event type breakdown

Malfunction10

Other1

Most-reported manufacturers

Immucor2 Micro Typing Systems, Inc.2 Abbott Ireland1 Bio-rad Medica Diagnostics Gmbh1 Bio-rad Medical Diagnostics Gmbh1 Immucor, Inc1 Immucor, Inc.1 Ortho Clinical Diagnostics, Inc.1

Recalls

1 recall events for this product code

Ortho Clinical Diagnostics Inc
TerminatedUnknown
Urine Electrolyte Diluent, Product Code: 1112352 - Product Usage: used to dilute urine specimens for analysis of sodium (Na+) and potassium (K+) on VITROS 250/3
Potential for the instability of the diluents VITROS 7% BSA (Product Code 8262487) and VITROS Urine Electrolyte Diluent (UED) (Product Code 1110352) when stored in a 2mL cup for 7 days.
Z-0740-2020 · View FDA record ↗

Registered firms

35 firms currently registered for this product code

510(k) clearances

13 clearances for this product code