Agency classClass IIOur severity:High FDA (Devices)·Z-0968-2018·Announced 2018-03-21

BD Vacutainer K2 EDTA Blood Collection Tubes Recalled for Additive Deficiency

Becton Dickinson is recalling specific lots of BD Vacutainer K2 EDTA blood collection tubes because they may contain insufficient anticoagulant, potentially causing erroneous test results.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a risk of harm (misdiagnosis or treatment delay) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Becton Dickinson & Company is recalling a limited portion of BD Vacutainer K2 EDTA (K2E) 3.6mg Blood Collection Tubes, Catalog Number 367841, Lot No. 6279849. These tubes are used for whole blood hematology determinations, immunohematology testing, and blood donor screening. The recall affects 8,494,000 units that were distributed nationwide.

The recall was initiated because a limited portion of the lot was manufactured with less than the required amount of K2EDTA additive, an anticoagulant. This deficiency may cause erroneous test results, which could lead to specimen recollection and potential delays in treatment or misdiagnosis/mismanagement of treatment. Serious complications, such as failure to detect thrombocytosis or postponing surgery, are possible consequences of these erroneous results.

Healthcare facilities and laboratories should check their inventory for the specific catalog and lot numbers listed above. If the affected tubes are found, they should be removed from use and returned to Becton Dickinson & Company according to the firm's instructions.

The recalled product

Product: BD Vacutainer¿ K2 EDTA (K2E) 3.6mg Blood Collection Tube (13 x 75 mm x 2.0 mL). Catalog Number: 367841. Used for whole blood hematology determinations, immunohematology testing and blood donor screening.
Manufacturer: Becton Dickinson & Company
Category: Medical Device — Blood Collection Tubes
Hazard: misdiagnosis
treatment-delay
Affected units: 8,494,000

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)

Catalog No. 367841 Lot No. 6279849 UDI: (01)30382903678410

Distribution

Distributed nationwide across the United States.

Same manufacturer · Becton Dickinson & Company

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