FDA Device recall Z-0138-2025
Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing Levels 1 & 2 6 X 15 mL-IVD intended as a control for urinalysis…
- FDA Device
- Class II
- ongoing
- Published 2024-10-30
On 2024-10-30 the FDA classified a Class II recall of Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing Levels 1 & 2 6 X 15 mL-IVD intended as a control for urinalysis… by Mckesson Medical Surgical Corporate Office, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0138-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-09-17 |
| Published | 2024-10-30 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Mckesson Medical Surgical Corporate Office |
| Distribution | US |
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
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.
Identifiers
| code_info | UDI-DI: 896863002134 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0138-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.