Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick… — Class II medical device recall Z-0138-2025
Ongoing recall by Mckesson Medical-Surgical Inc. Corporate Office, reported 2024-10-30, distributed nationwide. The Quantimetrix Dipper Urinalysis Dipstick control was shipped without the validated summer packaging and may
| Recall number | Z-0138-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mckesson Medical-Surgical Inc. Corporate Office, Richmond, VA, United States |
| Recall initiated | 2024-09-17 |
| Classified | 2024-10-22 |
| Reported by FDA | 2024-10-30 |
| Distributed | Nationwide (US) |
| Quantity | 1 boxes |
| UPC / GTIN / UDI-DI | 00896863002134 |
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0138-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.