CLASS II ONGOING Device recall · Reported 30 Oct 2024 · FDA Enforcement Report
Quantimetrix Urine Chemistry Control Set Dipper Urinalysis recalled
Mckesson Medical-Surgical Inc. Corporate Office is recalling Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing Levels 1, distributed nationwide in the US. The recall was initiated on 17 Sep 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0138-2025
- FDA event ID
- 95410
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office, Richmond, VA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Sep 2024
- FDA classified
- 22 Oct 2024
- Reported
- 30 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Test Kits & Diagnostics
Timeline
| 17 Sep 2024 | Recall initiated by company | |
| 22 Oct 2024 | Classified by FDA | +35 days |
| 30 Oct 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution in the state of DC.
Questions about this recall
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.
Which lots are affected?
UDI-DI: 896863002134
Where was it sold?
US Nationwide distribution in the state of DC.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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