MesaLabs Conductivity Standard Solution Recalled for Specification Failure
Mesa Laboratories is recalling 9,900 units of Conductivity/TDS Calibrator Solution because the product failed to meet specifications. The solution is used for calibrating hemodialysis equipment and does not contact patients.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a failure to meet specifications for a calibration solution that does not come into contact with patients, representing a risk of inaccurate equipment calibration rather than direct physical injury or contamination.
Plain-English summary
Mesa Laboratories, Inc. is recalling 9,900 units of MesaLabs Conductivity Standard Solution, 14 mS/cm, 32 ounces (950 ml). The affected product is identified by Lot number ML-C14-1352 and Product Numbers 02.0027 and 020510. The recall was initiated because the product failed to meet product specifications.
The solution is a secondary standard used for the calibration of conductivity/TDS cells and measurement instruments. These instruments may be indicated for calibrating the conductivity measurement function of hemodialysis machines and water purification equipment for hemodialysis. The solutions are used remotely from the hemodialysis machine or water purification equipment and do not come into contact with the patient.
The product was distributed nationwide in the United States, to one customer in Canada, and to government, VA, and military entities. Consumers and facilities should stop using the affected lot and contact Mesa Laboratories for further instructions.
The recalled product
- Product
- MesaLabs Conductivity Standard Solution, 14 mS/cm, 32 ounces (950 ml). Product No. : 02.0027, 020510 (carton of 6 of 02.0027). Polyethylene bottle Conductivity/TDS Calibrator solutions are a secondary standard solution used for the calibration of conductivity/TDS cells…
- Manufacturer
- Mesa Laboratories, Inc.
- Affected units
- 9,900
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot number: ML-C14-1352
Distribution
Distributed nationwide across the United States.
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