BD Urine Collection Cups May Elevate Red Blood Cell Counts
Becton Dickinson is recalling urine collection cups that may cause slight red blood cell count elevations when used with specific analyzers.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source explicitly states the product will continue to ship to avoid impacting critical patient care and the hazard is a slight count elevation requiring confirmation, fitting the criteria for a voluntary precautionary recall or low-risk issue.
Plain-English summary
Becton Dickinson & Company is recalling its Urine Collection Kits (Cat. No. 364981) because the cups may contribute to a slight elevation of Red Blood Cell (RBC) counts when used with Sysmex UF Series Analyzers. The recall involves 29,982,150 units in the US and 97,800,900 units outside the US, with distribution noted in Illinois. All lots within expiry are affected.
The product will continue to ship to avoid impacting critical patient care. Becton Dickinson recommends following Good Clinical Practice (GCP) guidelines, specifically using microscopy to confirm any elevated RBC counts in urine samples as per CLSI GP16-3A and CAP Checklist on Urinalysis.
The recalled product
- Product
- KIT URIN CUP PLC 16X100 10.0 UA YEL, Cat. No. 364981: Urine Collection Kit for collection and transport of urine specimens for urinalysis
- Manufacturer
- Becton Dickinson & Company
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots within expiry
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 4 recalled by Becton Dickinson & Company under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Becton Dickinson & Company
See all →- SevereBD Quincke spinal trays recalled over Huons bupivacaine quality issues
FDA (Devices) · 2026-06-10
- SevereBD Whitacre 24 gauge spinal trays recalled over bupivacaine quality issues
FDA (Devices) · 2026-06-10
- SevereBD Whitacre 22G spinal trays recalled in Huons bupivacaine sub-recall
FDA (Devices) · 2026-06-10
- SevereBD Whitacre spinal trays across nine catalog numbers recalled over bupivacaine
FDA (Devices) · 2026-06-10
- SevereBD spinal trays recalled as a sub-recall of Huons bupivacaine
FDA (Devices) · 2026-06-10
Same hazard · false positive
See all →- HighHealthmark ProChek-II Medical Tests Recalled for Expired Ingredient
FDA (Devices) · 2026-09-02
- HighAmyloid 1-42-N plasma calibrators recalled over falsely elevated results
FDA (Devices) · 2026-02-11
- HighpTau 217 plasma cartridges recalled over falsely elevated ratio results
FDA (Devices) · 2026-02-11
- HighpTau 217 plasma calibrators recalled over falsely elevated ratio results
FDA (Devices) · 2026-02-11
- HighAmyloid 1-42-N plasma cartridges recalled over falsely elevated results
FDA (Devices) · 2026-02-11