GKEClass I
Osmotic Fragility Testing
Hematology · 21 CFR 864.6600
MDR events0All time
Recalls2All time
Registered firms0Currently listed
510(k) clearances0All time
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
2 recall events for this product code
- Advanced Instruments, Inc.TerminatedApr 26, 2011
Advanced Instrument Model 2020 Multi-Sample Osmometer
A poorly soldered power cord may pose a potential electrical shock hazard.
Z-2068-2011 · View FDA record ↗ - Becton Dickinson & CompanyTerminatedAug 26, 2006
BD Unopette -- System Tests (Erythrocyte Fragility Test Kit). Catalog # 365830, Exp Date 2006-06, Manufactured by BD in San Lorenzo, Puerto Rico.
Formulation problems-lower pH of the solutions may increase Red Blood Cell hemolysis
Z-1446-06 · View FDA record ↗
Registered firms
0 firms currently registered for this product code
No registered firms found for this product code.
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.