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 is classified as FDA Class II, and the hazard involves a risk of harm (erroneous results or treatment delay) without reported injuries or illnesses, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Becton Dickinson & Company is recalling specific lots of BD Vacutainer PLUS K2EDTA Tubes (Plastic). These blood collection 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 affects 29,815,600 units distributed in the United States and internationally in the European Union, People's Republic of China, Japan, and Republic of Korea.
The recall is being issued because some of the blood collection tubes in the affected 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.
Healthcare facilities and laboratories should identify and stop using the affected lots. The specific lot numbers involved are 5064684, 5120653, 5154643, 5175930, 5210765, and 5237787, associated with Catalog Reference #367855. Users should contact Becton Dickinson & Company for further instructions regarding the return or disposal of these products.
The recalled product
- Product
- BD Vacutainer PLUS K2EDTA Tubes (Plastic). 13 x 75 mm x 3.0 mL (Tan) BD Hemogard Additive: K2EDTA (spray dried), 5.4mg 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 seru
- 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 (7)
- Catalog Reference #367855
- Lot numbers 5064684
- 5120653
- 5154643
- 5175930
- 5210765
- 5237787
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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