inforMED
JPHClass I

Test, Erythrocyte Sedimentation Rate

Hematology · 21 CFR 864.6700

MDR events14All time
Recalls0All time
Registered firms16Currently listed
510(k) clearances7All time

Recent MDR events

14 adverse event reports on file

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Event type breakdown

Malfunction12
Injury2

Most-reported manufacturers

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Becton Dickinson7Polymedco, Inc.2Emd Chemicals Inc.1Hema Technologies1Lp Italiana1Lp Italiana Spa1Smith & Nephew, Inc.1

Product problems

Reported product problem codes, most common first

Incorrect, Inadequate or Imprecise Result or Readings7
Fluid/Blood Leak2
Use of Device Problem2
Explosion1
Improper or Incorrect Procedure or Method1
Incorrect Or Inadequate Test Results1
Leak/Splash1
Material Integrity Problem1

Trend for “Incorrect, Inadequate or Imprecise Result or Readings”

No history to chart.

Recalls

0 recall events for this product code

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No recalls on file for this product code.

Registered firms

16 firms currently registered for this product code

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510(k) clearances

7 clearances for this product code

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