NIPRO Conductivity Standard Solution recalled for inaccurate calibration values
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.
From the FDA notice · Read the official notice ↗ · All Nipro recalls
What to do
- 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
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 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
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
Details
- Units affected
- 499 units
- Illnesses reported
- None reported
- Manufactured in
- 3110 N Oakland Ste 101, N/A, Mesa, AZ, United States
- Classification
- Class II
- Recall number
- Z-1185-2026
In the FDA's words
- Description
- 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 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. Catalog/Model Numbers/ Lot Numbers / UDI codes: 10001 14250616-1019106 (01) 0 0850016 97600 0 (17) 251030 (10) SHOWCASE 10011 14250616-1019107 (01) 0 0850016 97609 3 (17) 251030 (10) SHOWCASE 10040c 50250624-1019120 (01) 0 0850016 97636 9 (17) 251030 (10) SHOWCASE 10040 50250624-1019119 (01) 0 0850016 97635 2 (17) 251030 (10) SHOWCASE 10032 14250616-1019108 (01) 0 0850016 97631 1 (17) 251030 (10) SHOWCASE 10041 50250522-1018643 (01) 0 0850016 97637 6 (17) 251030 (10) SHOWCASE 10041 50250624-1019121 (01) 0 0850016 97637 6 (17) 251030 (10) SHOWCASE 10021 15F250603-1018834 (01) 0 0850016 97619 2 (17) 251030 (10) SHOWCASE Distribution: 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 quantity: 499 units
- 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.