FDA-Device2026-02-04Class IIPROCESSING DEFECT

NIPRO Conductivity Standard Solution recalled for inaccurate calibration values

OTHERNationwide distributionMedical devices

What this means

NIPRO Technical Services' Conductivity Standard Solutions (models 10001, 10011, 10021, 10032, 10040, 10040c, 10041) have a defect that causes incorrect conductivity readings. These solutions are used to calibrate meters that measure dialysate (the fluid used in dialysis treatment). If calibration is inaccurate, dialysis machines may report wrong conductivity values, which could affect treatment safety.

Stop using affected NIPRO Conductivity Standard Solution immediately
Check your inventory for model numbers 10001, 10011, 10021, 10032, 10040, 10040c, or 10041 with lot number 251030
Contact NIPRO Technical Services for a replacement or refund
Recalibrate your conductivity meters with a replacement solution from an approved supplier

The agency's original wording

Hazard

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.

Intended for

All ages

Illnesses reported

None reported

Sold states

U.S. Nationwide distribution in the states of AL, AR, AZ, CA, DE, FL, GA. IL, IN, KS, MI, MO, NC, ND, NJ, NV, NY, OH, OK, OR, PA, SC, TN TX, UT, VA, and WA.

Affected count

499 units

Manufactured in

3110 N Oakland Ste 101, N/A, Mesa, AZ, United States

Products

Conductivity Standard Solution Catalog/Model Numbers: 10001, 10011, 10021, 10032, 10040, 10040c, and 10041 Conductivity Standard Solutions are a secondary standard solution used for the calibration of conductivity cells together with conductivity meters

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1185-2026

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