CHWClass II
Titrimetric With Edta And Indicator, Calcium
Clinical Chemistry · 21 CFR 862.1145
MDR events106All time
Recalls0All time
Registered firms3Currently listed
510(k) clearances3All time
Recent MDR events
106 adverse event reports on file
- CALCIUM GEN.2Jul 15, 2026MalfunctionRoche Diagnostics1823260-2026-02866
- CALCIUM GEN.2Jul 13, 2026MalfunctionRoche Diagnostics1823260-2026-02832
- CALCIUM GEN.2Jul 10, 2026MalfunctionRoche Diagnostics1823260-2026-02795
- CALCIUM GEN.2Jul 1, 2026MalfunctionRoche Diagnostics1823260-2026-02634
- CALCIUM GEN.2Jul 1, 2026MalfunctionRoche Diagnostics1823260-2026-02637
- CALCIUM GEN.2Jun 24, 2026MalfunctionRoche Diagnostics1823260-2026-02528
- CALCIUM GEN.2Jun 15, 2026MalfunctionRoche Diagnostics1823260-2026-02374
- CALCIUM GEN.2Jun 10, 2026MalfunctionRoche Diagnostics1823260-2026-02291
- CALCIUM GEN.2May 20, 2026MalfunctionRoche Diagnostics1823260-2026-01987
- CALCIUM GEN.2May 8, 2026MalfunctionRoche Diagnostics1823260-2026-01799
Event type breakdown
Malfunction106
Most-reported manufacturers
Product problems
Reported product problem codes, most common first
Non Reproducible Results42
Low Test Results35
High Test Results28
Incorrect, Inadequate or Imprecise Result or Readings25
Output Problem4
Incorrect Measurement3
Optical Problem2
Unable to Obtain Readings2
Trend for “Non Reproducible Results”
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
3 firms currently registered for this product code