Lower riskMedical device recall · FDA · Published April 20, 2020
Alere Professional Urine Drug Controls Recall: Misdiagnosis Risk from Temperature Abuse
Cardinal Health recalls Alere Professional Urine Drug Controls with improper refrigeration causing misdiagnosis. Affected units may lead to incorrect test results if stored outside approved temperatures.
Three products requiring refrigerated storage conditions were incorrectly stored outside of approved temperature ranges. Using these temperature abused products may result in misdiagnosis of the patient.
Take action
Contact the company
📍Recalling firmCardinal Health Inc.7000 Cardinal Pl · Dublin, OH 43017-1091
“Alere Professional Urine Drug Controls Recall: Misdiagnosis Risk from Temperature Abuse.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65351-alere-professional-urine-drug-controls-recall-misdiagnosis-risk-from-temperature. Based on FDA recall #Z-2050-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2050-2020%22&limit=1).
Cardinal Health Inc. recalled Alere Professional Cup Urine Drug Controls, Item code 88010, due to improper storage temperatures that may cause patient misdiagnosis, the FDA said on April 20, 2020.
How to tell if you have it
Brand: Alere
Product: Professional Urine Drug Control, Item code 88010
Lot code: KN00146
The hazard
Three products requiring refrigerated storage were incorrectly stored outside approved temperature ranges. Using these temperature-abused products may result in misdiagnosis of the patient.
Context
GovInfoNow's records show Cardinal Health Inc. has 11 other recalls on record since November 16, 2018. Other recent recalls include an Enoxaparin syringe recall due to wrong labeling on August 5, 2025, and a Wegovy injection recall for temperature abuse risk on April 9, 2025.
How to tell if you have this one
Check for the product code 88010 with lot number KN00146. These Alere Professional Urine Drug Controls were sold with improper refrigeration conditions.
Brand
Alere
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
US Nationwide distribution NC, KS, and AL.
Recall number
Product, codes & lots
Z-2049-2020
B-Hydroxybutyrate LiquiColor, Item code CH2440058 - Product Usage: Product is used for the quantitative determination of B-Hydroxybutyrate in human serum or plasma.; Lot 193462
Z-2050-2020
Professional Urine Drug Control, Item code 88010 - Product Usage: The Alere Professional Cup Urine Drug Controls are compatible with all quantitative and qualitative drug detection procedures which are sufficiently sensitive to detect the control constituents.; Lot KN00146
Z-2051-2020
Strep B Carrot Broth One-Step, 16x100mm Tube, 6ml, Item code Z46BX - Product Usage: Intended to detect Group B Streptococcus (GBS) from anovaginal specimen collected from pregnant women. If pregnant woman is positive for GBS colonization, this will indicate a need for treatment prior to vaginal delivery in order to prevent infection of the neonate.; All lots
Based on the official FDA remedy
What to do — step by step
Check Storage Conditions
Verify if the product was stored outside the approved refrigeration temperature range.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 3 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution NC, KS, and AL.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Kansas, North Carolina.
Recall timeline
FDA terminated this recall 3 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-2050-2020 (April 20, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2050-2020 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.