JJCClass I

Analyzer, Chemistry (sequential Multiple, Continuous Flow) Clinical Use

Clinical Chemistry · 21 CFR 862.2150

MDR events354All time

Recalls1All time

Registered firms20Currently listed

510(k) clearances32All time

Recent MDR events

354 adverse event reports on file

Event type breakdown

Malfunction264

Other56

Injury20

Unspecified12

Death2

Most-reported manufacturers

Beckman Coulter Inc.102 Roche Diagnostics53 Beckman Coulter, Inc.48 Abbott Manufacturing, Inc.16 Dade International Inc.14 Beckman Instruments, Inc.13 Abbott Diagnostics7 Abbott Manufacturing Inc6

Recalls

1 recall events for this product code

Hamilton Co
TerminatedOct 22, 2005
Y-valve and T-valve, PSD/4 Syringe Drive Module parts.
The product valve has a high probability of deforming and may result in leakage during use.
Z-0087-06 · View FDA record ↗

Registered firms

20 firms currently registered for this product code

510(k) clearances

32 clearances for this product code