Lower riskMedical device recall · FDA · Published August 30, 2018
BD Vacutainer Urine Cups May Cause Slight RBC Elevation with Sysmex Analyzers
BD Vacut: Urine collection cups may cause slight red blood cell elevation when used with Sysmex analyzers. Follow GCP guidelines for urine testing to ensure accurate results.
BD Vacutainer Urine Collection Cups may contribute to a slight elevation of Red Blood Cell (RBC) counts when used with the Sysmex UF Series Analyzers. BD recommends following Good Clinical Practice (GCP) by using microscopy to confirm an elevated RBC Count in a Urine sample as per CLSI GP16-3A. 29(4) and CAP Checklist on Urinalysis. Product will continue to ship to not impact critical patient care.
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Contact the company
📍Recalling firmBecton Dickinson & Company1 Becton Dr · Franklin Lakes, NJ 07417-1815
“BD Vacutainer Urine Cups May Cause Slight RBC Elevation with Sysmex Analyzers.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69933-bd-vacutainer-urine-cups-may-cause-slight-rbc-elevation-with. Based on FDA recall #Z-0491-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0491-2019%22&limit=1).
Becton Dickinson & Company voluntarily recalled BD Vacutainer Urine Collection Cups, Cat. No. 364941, due to a potential elevation of red blood cell counts when used with specific analyzers, according to the FDA. The Food and Drug Administration announced the Class II recall on August 30, 2018.
How to tell if you have it
Brand: Becton Dickinson
Product: BD Vacutainer Urine Collection Cups
Catalog Number: Cat. No. 364941
Lots: All lots within expiry
The hazard
The BD Vacutainer Urine Collection Cups may contribute to a slight elevation of Red Blood Cell (RBC) counts when used with the Sysmex UF Series Analyzers. BD recommends following Good Clinical Practice by using microscopy to confirm an elevated RBC Count in a urine sample as per CLSI GP16-3A. 29(4) and CAP Checklist on Urinalysis.
Context
GovInfoNow's records show Becton Dickinson & Company has 52 other recalls on record since May 31, 2017. Recent recalls include a spinal tray recall for quality issues identified during an FDA inspection on April 27, 2026, and a recall of 10mL non-sterile Luer-Lok syringes due to wrong syringe type on January 27, 2026. Other recent recalls of similar products include a Luer tip caps recall for failed biocompatibility testing on October 14, 2025.
How to tell if you have this one
Check for BD Vacutainer Urine Collection Cups with model number 364941. All lots within their expiration date are affected.
Brand
Becton Dickinson
Category
Medical device
FDA recall event · 4 products
All 4 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
Illinois
Recall number
Product, codes & lots
Z-0491-2019
BD Vacutainer Urine Collection Cups, Cat. No. 364941; All lots within expiry
Z-0492-2019
BD Vacutainer Specimen Collection Cups, Cat. No. 364975; All lots within expiry
Z-0493-2019
KIT URIN CUP PLC 16X100 10.0 UA YEL, Cat. No. 364981: Urine Collection Kit for collection and transport of urine specimens for urinalysis; All lots within expiry
Z-0494-2019
KIT URIN CUP 16X100 8.0 CONI UA YEL, Cat. No. 364989 BD Vacutainer Urine Cup Kit with UA Tube for Midstream Specimens; All lots within expiry
Based on the official FDA remedy
What to do — step by step
Confirm Urine Test Results
Use microscopy to verify elevated red blood cell counts in urine samples as per CLSI GP16-3A guidelines.
Where it went and when
Where it was distributed
Distributed in Illinois.
Listed by the agency
Not listed
FDA distribution: “Illinois” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Illinois.
Recall timeline
FDA terminated this recall 2.1 years 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-0491-2019 (August 30, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0491-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.