Solution-test Standard-conductivity, Dialysis
Gastroenterology, Urology · 21 CFR 876.5820
Recent MDR events
3 adverse event reports on file
- MESA LABORATORIES 7.0 PH SOLUTIONOct 3, 2013MalfunctionMesa Laboratories3670470
- MESA LABORATORIES 7.0 PH SOLUTIONOct 2, 2013MalfunctionMesa Laboratories Inc3410542
- VESICA PERC STABILIZATION KIT WITH PROTEGEN SLINGJul 10, 2002InjuryMicrovasive Urology/a Division Of Boston Scientific Corp.6000043-2002-00087
Event type breakdown
Most-reported manufacturers
Recalls
2 recall events for this product code
- NIPRO Technical Services, Inc.Open, ClassifiedJan 27, 2026
Conductivity Standard Solution
due to a defect associated with the conductivity values of the solution used to calibrate meters and result in the reporting of incorrect conductivity values for dialysate.
Z-1185-2026 · View FDA record ↗ - Mesa Laboratories, Inc.TerminatedMay 16, 2017
MesaLabs Conductivity Standard Solution, 14 mS/cm, 32 ounces (950 ml). Product No. : 02.0027, 020510 (carton of 6 of 02.0027). Polyethylene bottle
Mesa Laboratories is recalling Conductivity/TDS Calibrator Solution due to failure to meet product specifications.
Z-2159-2017 · View FDA record ↗
Registered firms
6 firms currently registered for this product code
510(k) clearances
8 clearances for this product code
- Mesa Laboratories, Inc.Aug 5, 2019
K191496 · TDS Standard Solution
- Mesa Laboratories, Inc.Apr 18, 2013
K130100 · COMINED STANDARD SOLUTION
- H & S Technical ServicesJul 2, 2004
K041636 · H&S-CONDUCTIVITY STANDARD SOLUTION
- Mesa Laboratories, Inc.Feb 27, 2004
K033330 · CONDUCTIVITY/TDS CALIBRATOR SOLUTION
- Ibp Instruments GmbHSep 17, 2003
K032075 · CONDUCTIVITY STANDARD SOLUTION-METERCARE
- D.R.G. Scientific IndustriesOct 24, 1986
K863824 · SOLUTION/TEST STANDARD/CONDUCT. DIALY.&MULT.SOLUT.
- Rna Medical Corp.Jun 12, 1985
K851362 · STANDARD SOLUTION OF CONDUCTIVITY & MEASUREMENT OF
- Amisco Trading Corp.Sep 24, 1981
K812622 · HEMODIALYSIS VENOUS & ARTERIAL SET