Conductivity standard solutions recalled over incorrect dialysate conductivity values
NIPRO Technical Services is recalling 499 units of Conductivity Standard Solution because a defect in the solution can cause meters to report incorrect conductivity values for dialysate.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the firm states the defect results in incorrect reported conductivity values for dialysate, and no injuries are reported.
Plain-English summary
Conductivity Standard Solution, catalog/model numbers 10001, 10011, 10021, 10032, 10040, 10040c and 10041, is being recalled by NIPRO Technical Services, Inc. The record describes the product as a secondary standard solution used for the calibration of conductivity cells together with conductivity meters.
The reason given in the enforcement record is a defect associated with the conductivity values of the solution used to calibrate meters, which can result in the reporting of incorrect conductivity values for dialysate.
The record lists 499 units, with catalog/model numbers, lot numbers and UDI codes recorded in the enforcement record. Distribution was nationwide in the United States across the states listed in the record. The FDA has classified the action as Class II.
An incorrectly calibrated meter reports a dialysate conductivity value that clinicians rely on. The enforcement record reports no injuries. Facilities should quarantine affected stock and follow NIPRO's instructions.
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
- Manufacturer
- NIPRO Technical Services, Inc.
- Affected units
- 499
Distribution
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