FDA Medical devices recall ·
Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick… recall
- Recall number
- Z-0138-2025
- Date
- (initiated September 17, 2024)
- Company / brand
- Mckesson Medical-Surgical Inc. Corporate Office
9954 Maryland Drive, Richmond, VA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1 BOX
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
The Quantimetrix Dipper Urinalysis Dipstick control was shipped without the validated summer packaging and may have been exposed to temperatures above 25¿C. This may lead to delay in patients' results.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 896863002134
Distribution
US Nationwide distribution in the state of DC.
States: District of Columbia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0138-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.