BD Vacutainer Urine Cup Kit Recall for Potential RBC Count Elevation
Becton Dickinson is recalling BD Vacutainer Urine Cup Kits because they may cause slight red blood cell count elevations when used with specific analyzers.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 hazard is a potential slight elevation in RBC counts rather than a direct injury or high-risk pathogen, fitting the criteria for moderate severity involving low-risk contamination or precautionary measures.
Plain-English summary
Becton Dickinson & Company is recalling BD Vacutainer Urine Cup Kits with UA Tubes for Midstream Specimens, Catalog Number 364989. The recall involves approximately 29.9 million units in the United States and 97.8 million units outside the US. The distribution pattern is listed as Illinois, and all lots within expiry are affected.
The recall is issued because the urine collection cups may contribute to a slight elevation of Red Blood Cell (RBC) counts when used with Sysmex UF Series Analyzers. This potential interference could impact the accuracy of urinalysis results.
Becton Dickinson recommends that healthcare providers follow Good Clinical Practice (GCP) guidelines by using microscopy to confirm any elevated RBC counts in urine samples, in accordance with CLSI GP16-3A and CAP Checklist on Urinalysis standards. The product will continue to ship to avoid impacting critical patient care.
The recalled product
- Product
- KIT URIN CUP 16X100 8.0 CONI UA YEL, Cat. No. 364989 BD Vacutainer Urine Cup Kit with UA Tube for Midstream Specimens
- 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.
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