Quantimetrix Urine Chemistry Control Set Recalled for Temperature Exposure
Mckesson Medical-Surgical is recalling Quantimetrix Urine Chemistry Control Sets shipped without validated summer packaging, potentially exposing them to temperatures above 25°C.
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 is a potential delay in patient results due to temperature exposure, which is a functional defect rather than a direct physical injury or high-risk pathogen exposure, fitting the Moderate criteria for low-risk contamination or functional issues without reported harm.
Plain-English summary
Mckesson Medical-Surgical Inc. is recalling Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing Levels 1 & 2 (6 X 15 mL). The product is an in-vitro diagnostic (IVD) intended as a control for urinalysis reagent strips, microalbumin, and creatinine by listed test methods.
The recall was initiated because the control sets were shipped without the validated summer packaging. This packaging omission may have resulted in the product being exposed to temperatures above 25°C. The source text indicates that this temperature exposure may lead to a delay in patients' results.
The product was distributed nationwide in the United States, specifically within the District of Columbia. The recall number is Z-0138-2025, and the UDI-DI is 896863002134. Users should stop using the affected control sets and contact the recalling firm for further instructions.
The recalled product
- Product
- Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing Levels 1 & 2 6 X 15 mL-IVD intended as a control for urinalysis reagent strips, microalbumin, and creatinine by listed test methods.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Affected units
- 1
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)
- UDI-DI: 896863002134
Distribution
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