Beckman Coulter recalls IRISPEC CA/CB/CC Urine Chemistry Controls (REF 800-7211/7702) due to intermittent glucose control failures causing false positives with iChemVELOCITY strips. This may delay diagnosis of metabolic disorders and kidney issues.
Beckman Coulter has become aware of an increase in customer complaints for intermittent IRISpec CB negative glucose control failure, resulting in false positive control results when used in conjunction with iChemVELOCITY Urine Chemistry Strips (PNs 800-7204 and 800-7212) on the iChemVELOCITY Analyzer. This issue may delay the reporting of patient results, with a worst-case scenario of a delay in diagnosis or treatment of metabolic disorders, kidney function abnormalities, urinary tract infections, and liver function.
“Beckman Coulter IRISPEC Urine Controls Recall: False Glucose Results Risk Delayed.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54610-beckman-coulter-irispec-urine-controls-recall-false-glucose-results-risk. Based on FDA recall #Z-0093-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0093-2025%22&limit=1).
The FDA announced on July 16, 2024, that Beckman Coulter, Inc. is recalling its IRISPEC CA/CB/CC Urine Chemistry Controls due to potential false positive results. The agency issued Class III recall Z-0093-2025 for the in vitro diagnostic devices distributed worldwide.
The controls may fail intermittently, resulting in false positive control results when used with iChemVELOCITY Urine Chemistry Strips on the iChemVELOCITY Analyzer. This issue may delay patient result reporting, potentially delaying diagnosis or treatment for metabolic disorders, kidney function abnormalities, urinary tract infections, and liver function issues.
Context
GovInfoNow's records show Beckman Coulter, Inc. has 132 other recalls on record since June 20, 2017. Other recent recalls of similar products include Beckman Coulter DxC 500i Modules with Software 1.5 (July 15, 2026), Beckman Coulter MicroScan LabPro V5.03 Panel Update 11 (June 26, 2026), and Beckman Coulter Access Total T4 Calibrator Recall (March 16, 2026). Other recent recalls of similar products include Beckman Coulter Bicarbonate Reagent (October 14, 2025), Beckman Coulter Emit 2000 Quinidine Assay (July 13, 2026), and Changchun Wancheng Bio-Electron UTI Test Strips (November 22, 2025).
How to tell if you have this one
Check for catalog numbers REF 800-7211 or 800-7702 on the urine chemistry controls. The lot numbers start with 432-24. These products were sold with iChemVELOCITY analyzers.
Brand
Beckman Coulter
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Control Lot Number
Look for lot numbers starting with 432-24 on the urine chemistry controls.
Contact Manufacturer
Reach out to Beckman Coulter for guidance on whether your controls are affected.
How this recall unfolded
Recall timeline
FDA published this recall 3 months after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
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-0093-2025 (July 16, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0093-2025 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.