Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1570-2016·Announced 2016-05-04

BD Trucount Absolute Counting Tubes Recalled for Lot Mixing

Becton, Dickinson and Company is recalling one lot of BD Trucount tubes because some pouches may contain tubes from a different lot, presenting a low risk to patient safety.

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 source text explicitly states that the issue presents a 'low risk to patient safety or impact to data,' which aligns with the rubric criteria for a Moderate severity score involving low-risk contamination or voluntary precautionary recalls.

Plain-English summary

Becton, Dickinson and Company, BD Biosciences is recalling one lot of BD Trucount Absolute Counting Tubes, Model number 340334 IVD. The recall involves 1,743 units, distributed to 467 locations in the United States and 1,276 locations internationally. The affected manufacturing lot is 534964.

The recall was initiated because some pouches within the affected lot may contain tubes from another lot. This mixing results in a 3.3% difference in bead counts between the two lots. The manufacturer states that this discrepancy presents a low risk to patient safety or impact to data if the product is used.

The product is used for determining absolute counts of leucocytes in blood and is designed for use with in vitro diagnostic products such as BD Tritest reagents and a suitably equipped flow cytometer. The recall covers distribution in the US (including MD, CA, GA, WA, PA, CO, TN, FL, NC, DE, VA, CT, LA, NY, OH, MN, and NH) and internationally to China, Japan, and India.

The recalled product

Product: BD Trucount Absolute Counting Tubes: Model number: 340334 IVD; BD Trucount tubes are used for determining absolute counts of leucocytes in blood. BD Trucount tubes are designed for use with in vitro diagnostic products such as BD Tritest reagents, and a suitably equipped…
Manufacturer: Becton, Dickinson and Company, BD Biosciences
Category: Medical Device — In Vitro Diagnostics
Hazard: lot-mixing
data-accuracy

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 (2)

Model: 340334
Manufacaturing lot: 534964

Distribution

Distributed in 10 states:

Same manufacturer · Becton, Dickinson and Company, BD Biosciences

See all →

High
BD Multitest 6-Color TBNK Reagent Contamination May Cause Erroneous Results
FDA (Devices) · 2024-07-24
High
Medical diagnostic reagent recall: incorrect cell staining fluorescence
FDA (Devices) · 2024-01-17
High
BD Trucount Tubes for Blood Testing Recall Due to Label Detachment
FDA (Devices) · 2022-11-09
High
BD Trucount Tubes Recalled Due to Partial Label Detachment Causing Operational Failures
FDA (Devices) · 2022-11-09
Moderate
BD Multitest 6-Color TBNK tubes recalled for partial label detachment
FDA (Devices) · 2022-11-09

Same hazard · lot mixing