BD Vacutainer PLUS K2EDTA Tubes Recalled for Insufficient Additive
Becton Dickinson is recalling specific lots of BD Vacutainer PLUS K2EDTA tubes because some were manufactured with insufficient EDTA additive, which may lead to erroneous platelet results.
What this means for you
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 involves a risk-of-harm product where the hazard is a delay of treatment or erroneous results, but no specific injuries or illnesses are reported in the source text, fitting the High severity criteria.
Plain-English summary
Becton Dickinson & Company is recalling specific lots of BD Vacutainer PLUS K2EDTA Tubes (Plastic). The affected product is identified by Catalog Reference #368047 and Lot number 5154647. A total of 29,815,600 units are involved in this recall. These tubes are used to collect, transport, and process blood in a closed system for clinical laboratory testing, including routine immunohematology testing and blood donor screening.
The recall was initiated because some of the blood collection tubes in these lots were manufactured with insufficient EDTA additive. The presence of insufficient EDTA additive may lead to erroneous platelet results, specimen recollection, or a delay of treatment.
The affected units were distributed worldwide, including the United States (nationwide), the European Union, the People's Republic of China, Japan, and the Republic of Korea. Users of these products should check their inventory for the specific catalog reference and lot number listed above and discontinue use of the affected units.
The recalled product
- Product
- BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 2.0 mL (Pink) BD Hemogard Additive: K2EDTA (spray dried), 3.6mg Sterile IVD BD, Made in USA BD Vacutainer¿ tubes are used to collect, transport and process blood in a closed system. These tubes are used for testing ser
- Manufacturer
- Becton Dickinson & Company
- Affected units
- 29,815,600
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)
- Catalog Reference #368047
- Lot number 5154647
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 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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