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Lower risk Medical device recall · FDA · Published September 17, 2024

Quantimetrix Urine Dipstick Control Sets: Risk of Delayed Test Results

Mckesson Medical-Surgical recalls Quantimetrix Urine Chemistry Control Sets due to potential temperature exposure causing delayed patient test results. Affected units may have been shipped without proper packaging.

🇺🇸 FDA recall #Z-0138-2025Medical deviceMckesson Medical-Surgical ›
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Contact the company

Recalling firmMckesson Medical-Surgical Inc. Corporate Office9954 Maryland Drive, Deep Run Iii Ste. 4000 · Richmond, VA 23233
✎ GovInfoNow plain-language explainer

Mckesson Medical-Surgical recalls Quantimetrix Urine Chemistry Control Sets that may have been exposed to high temperatures, which could delay patient test results. This is a safety issue for healthcare providers using these dipsticks in clinical settings. Read more at govinfonow.com/recall/54018-quantimetrix-urine-dipstick-control-sets-risk-of-delayed-test-results.

Source Summary by GovInfoNow · govinfonow.com/recall/54018-quantimetrix-urine-dipstick-control-sets-risk-of-delayed-test-results · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0138-2025

Cite this page

“Quantimetrix Urine Dipstick Control Sets: Risk of Delayed Test Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54018-quantimetrix-urine-dipstick-control-sets-risk-of-delayed-test-results. Based on FDA recall #Z-0138-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0138-2025%22&limit=1).

The FDA announced on 2024-09-17 that Mckesson Medical-Surgical Inc. Corporate Office is recalling Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing Levels 1 & 6 X 15 mL-IVD because the product may have been exposed to temperatures above 25°C, potentially delaying patient results.

How to tell if you have it

  • Brand: Mckesson Medical-Surgical
  • Product: Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing Levels 1 & 2 6 X 15 mL-IVD
  • UDI-DI: 896863002134
  • Quantity: 1 BOX
  • Distribution: US Nationwide distribution in the state of DC

The hazard

The Quantimetrix Dipper Urinalysis Dipstick control was shipped without validated summer packaging and may have been exposed to temperatures above 25°C, which may lead to delay in patients' results.

Context

GovInfoNow's records show Mckesson Medical-Surgical Inc. Corporate Office has 14 other recalls on record since 2021-06-02. Other recent recalls of similar products include Siemens Healthcare Syva EMIT 2000 Quinidine Assay Recall (2026-07-13), ICU Medical Hotline Fluid Warming Set Recall (2026-06-24), and The Girlfriend Doctor Keto-pH-Uric Acid Test Strips (2025-11-22).

How to tell if you have this one

Check for Quantimetrix Urine Chemistry Control Sets with the model '6 X 15 mL' sold as IVD (intended for use in clinical settings). The product has a UDI-DI code 896863002134.

  • Brand
    Mckesson Medical-Surgical
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Verify if your Quantimetrix Urine Chemistry Control Set has the model '6 X 15 mL' and UDI-DI code 896863002134.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution in the state of DC.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 43 days after the firm started it.

1. Firm started the recall: Sep 17, 202412. FDA classified it Class II: Oct 22, 202423. Published in FDA’s Enforcement Report: Oct 30, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

What should I do if I have this product?

Check if your product matches the model and UDI-DI code listed in the recall. If it does, you may need to contact Mckesson Medical-Surgical for further instructions.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0138-2025 (September 17, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0138-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA