Lower riskMedical device recall · FDA · Published January 6, 2022
BD Vacutainer Luer Lok Device May Cause False Red Blood Cell Counts in Urine Tests
Becton Dickinson recalls BD Vacutainer Luer Lok Access Devices that may shed contaminants into urine samples, leading to false high red blood cell counts when used with certain analyzers.
May shed contaminant particles into the urine specimen that may be misidentified as Red Blood Cells when used in conjunction with the Sysmex UF-1000i or UX-2000 Analyzers and lead to false elevations in RBC counts
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Contact the company
📍Recalling firmBecton Dickinson & Company1 Becton Dr · Franklin Lakes, NJ 07417-1815
✎ GovInfoNow plain-language explainer
Becton Dickinson is recalling BD Vacutainer Luer Lok Access Devices that can cause false elevations in red blood cell counts in urine tests when used with specific analyzers. This could lead to incorrect test results and potential misdiagnosis. Read more at govinfonow.com/recall/61311-bd-vacutainer-luer-lok-device-may-cause-false-red-blood.
“BD Vacutainer Luer Lok Device May Cause False Red Blood Cell Counts in Urine Tests.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61311-bd-vacutainer-luer-lok-device-may-cause-false-red-blood. Based on FDA recall #Z-0665-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0665-2022%22&limit=1).
Becton Dickinson & Company recalled BD Vacutainer Luer Lok Access Devices on Jan. 6, 2022, according to the FDA. The sterile single-use devices may shed particles into urine specimens, leading to false red blood cell counts when used with specific Sysmex analyzers.
How to tell if you have it
BD Vacutainer Luer Lok Access Device
UPC 50382903649025
UPC 60382903649022
The hazard
The devices may shed contaminant particles into urine specimens. These particles may be misidentified as red blood cells when used with Sysmex UF-1000i or UX-2000 Analyzers, leading to false elevations in RBC counts.
Context
GovInfoNow's records show Becton Dickinson & Company has 52 other recalls on record since May 31, 2017. Other recent recalls of similar products include LH One Step Ovulation Test Device Recall (Nov. 22, 2025), Cepheid Xpert BCR-ABL Ultra Test Kits May Give Inaccurate Results (Oct. 30, 2025), and Changchun Wancheng Bio-Electron UTI Test Strips Recall (Nov. 22, 2025).
How to tell if you have this one
Check for catalog numbers 364902 or 36490200 on the device. The product was sold with all lots within expiry dates.
Brand
Becton Dickinson
Product
BD Vacutainer Luer Lok Access Device
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Details
Look for catalog numbers 364902 or 36490200 on the device.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution in the state of IL.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 55 days 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-0665-2022 (January 6, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0665-2022 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.