Quantimetrix Urine Chemistry Control Set Dipper Urinalysis… recallZ-0138-2025 · Mckesson Medical-Surgical Inc. Corporate Office · initiated Sep 17, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Mckesson Medical-Surgical Inc. Corporate Office or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The Quantimetrix Dipper Urinalysis Dipstick control was shipped without the validated summer packaging and may have been exposed to temperatures above 25C. This may lead to delay in patients' results.
FDA root cause category: Packaging process control
What the company is doing
McKesson issued Urgent Product Recall letter via FedEx Overnight service scheduled for delivery on 9/17/24 to one consignee. Letter states reason for recall, health risk and action to take: 1. Immediately examine your inventory and quarantine all product subject to this urgent product recall detailed in the affected products list (Attachment #1). 2. Please complete, sign, and return the enclosed response form (Attachment #2 - Customer Response Form) as soon as possible, even if you do not have any product on hand. Return completed signed form [email protected]. 3. If you have any product, destroy using your local procedures and document the destruction on attached customer response form (Attachment #2 - Customer Response Form). Return completed signed form [email protected]. 4. If you have further distributed this product, please notify them immediately of this urgent product recall. You are encouraged to include a copy of this notification letter in your communication. If you have questions regarding this notification, please contact McKesson MedicalSurgical directly by phone at (800) 688-8840. Representatives are available Monday -Friday, 8:00 am - 5:00 pm.
Recall details
- Recall number
- Z-0138-2025
- Status
- Open, Classified
- Initiated by the company
- Sep 17, 2024
- Posted by the FDA
- Oct 22, 2024
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Quantity
- 1 BOX
- Product code
- JJW
- FDA submissions
- K874890
- Distribution
- US Nationwide distribution in the state of DC.
Product description
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.
Code information (models, lots, serial numbers)
UDI-DI: 896863002134
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Dipper Urinalysis Dipstick Control Level 1&2 Set 6x15mL 1440-01Quantimetrix Corporation · Urinalysis Controls (Assayed And Unassayed)1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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