# K981013: Vacutainer Plus Tube with Edta Anticoagulant Andd Vacutainer Plus Serum Tube

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Vacutainer Systems
- Decided: Jun 17, 1998 after 91 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: 8 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) VACUTAINER® Brand Serum Tube: named in the summary without a submission number
- (no number) VACUTAINER® Brand Tube with EDTA Anticoagulant: named in the summary without a submission number

## Most influential descendants
- K231373: BD Vacutainer® K2 EDTA Blood Collection Tubes (2024), 0 descendants of its own
- K213670: BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes (2023), 0 descendants of its own

## Recalls of this device
- Mar 22, 2018 · Class I · Z-1139-2018: BD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes and BD Vacutainer Lithium Heparin Green Top Tubes can cause an underestimation of lead in blood samples when used with Magellan Diagnostics LeadCar
- Mar 22, 2018 · Class I · Z-1141-2018: BD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes and BD Vacutainer Lithium Heparin Green Top Tubes can cause an underestimation of lead in blood samples when used with Magellan Diagnostics LeadCar
- Dec 3, 2015 · Class II · Z-0571-2016: Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additive. An insufficient EDTA additive may lead to erroneous platelet results, specimen recollection, or a de
- Dec 3, 2015 · Class II · Z-0567-2016: Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additive. An insufficient EDTA additive may lead to erroneous platelet results, specimen recollection, or a de
- Dec 3, 2015 · Class II · Z-0568-2016: Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additive. An insufficient EDTA additive may lead to erroneous platelet results, specimen recollection, or a de
- Dec 3, 2015 · Class II · Z-0569-2016: Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additive. An insufficient EDTA additive may lead to erroneous platelet results, specimen recollection, or a de
- Dec 3, 2015 · Class II · Z-0570-2016: Some of the Blood Collection Tubes in these lots were manufactured with insufficient EDTA additive. An insufficient EDTA additive may lead to erroneous platelet results, specimen recollection, or a de
- Nov 17, 2015 · Class II · Z-0456-2016: Some tubes were manufactured with the stopper not fully inserted into the tube. This may result in the stopper popping-off in a small number of instances which could lead to blood exposure and in some

## Indications for use
The VACUTAINER® Brand PLUS (plastic) Tube with EDTA and VACUTAINER® Brand Serum Tube are evacuated blood collection tubes which provide a means of collecting, transporting, separating and processing blood in a plastic tube. When the tube is used together with VACUTAINER® Brand Needles and Holders, it is a closed system for the collection of venous blood with the same indications as described herein. Blood collected in PLUS EDTA and PLUS Serum tubes can be used for inmunohematology testing including ABO Grouping, Rh typing and antibody screening which requires red cells and plasma or serum.

Source page: https://510kreport.com/device/K981013
Methodology: https://510kreport.com/methodology