Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0492-2019·Announced 2018-11-28

BD Vacutainer Urine Collection Cups Recalled for Potential RBC Count Elevation

Becton Dickinson is recalling BD Vacutainer Urine Collection Cups because they may cause slight elevations in red blood cell counts 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 source text describes the hazard as a 'slight elevation' of counts and notes the product will continue to ship to avoid impacting critical patient care, indicating a low-risk, theoretical hazard without reported injuries or illnesses.

Plain-English summary

Becton Dickinson & Company is recalling BD Vacutainer Specimen Collection Cups, Catalog Number 364975. The recall involves approximately 29.9 million units in the United States and 97.8 million units outside the United States. The product is distributed in Illinois, and all lots within their expiration dates are affected.

The recall is issued because the 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 following Good Clinical Practice guidelines, including using microscopy to confirm 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. Healthcare providers and laboratories should be aware of this potential interference when interpreting results from the affected analyzers.

The recalled product

Product: BD Vacutainer Specimen Collection Cups, Cat. No. 364975
Manufacturer: Becton Dickinson & Company
Category: Medical Device — Specimen Collection
Hazard: test-accuracy
false-positive

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 →

Same manufacturer · Becton Dickinson & Company

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Same hazard · test accuracy