Vacutainer Plus Tube with Edta Anticoagulant Andd Vacutainer Plus Serum Tube

510(k) K981013

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

8 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SN Traditional	NumberK981013	Date17 Jun 1998Decided	StatusActive

8 recalls · FDA

2 recalls, same reason
- Terminated Z-1141-2018 FDA Class I initiated 22 Mar 2018
- Terminated Z-1139-2018 FDA Class I initiated 22 Mar 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 LeadCare assays, employing the Anodic Stripping Voltammetry (ASV) methodology, or any other assay employing ASV methodology.
5 recalls, same reason
- Terminated Z-0569-2016 FDA Class II initiated 3 Dec 2015
- Terminated Z-0568-2016 FDA Class II initiated 3 Dec 2015
- Terminated Z-0570-2016 FDA Class II initiated 3 Dec 2015
- Terminated Z-0567-2016 FDA Class II initiated 3 Dec 2015
- Terminated Z-0571-2016 FDA Class II initiated 3 Dec 2015
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 delay of treatment.
- Terminated Z-0456-2016 FDA Class II initiated 17 Nov 2015
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 cases to blood splatter or spraying.

1 jurisdiction

United States — FDA 510(k) Active

510(k)