Z-0138-2025Class II

Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing Levels 1 & 2 6 X 15 mL-IVD...

Name: Z-0138-2025 Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing Levels 1 & 2 6 X 15 mL-IVD...
Creator: Mckesson Medical-Surgical Inc. Corporate Office
Published: 2024-09-17
License: https://open.fda.gov/license/

Mckesson Medical-Surgical Inc. Corporate Office / initiated 2024-09-17 / Open, Classified / root cause: packaging

FDA source

Mckesson Medical-Surgical Inc. Corporate Office began a 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 reagent strips... on 2024-09-17. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0138-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-09-17
Posted: 2024-10-22
Recalling firm: Mckesson Medical-Surgical Inc. Corporate Office
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.
Product code: JJW Urinalysis Controls (Assayed And Unassayed)
Reason for recall: 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.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: 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.
Quantity in commerce: 1 BOX
Distribution: US Nationwide distribution in the state of DC.
Product codes and lots: UDI-DI: 896863002134

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0138-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0138-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-30	2024-10-22

Product code JJW

K874890Class IQuantimetrix Urine Dipstick ControlQuantimetrix Medical Industries / cleared 1988-01-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)