# K971221: Greiner Vacuette Blood Collection Tube

- Pathway: 510(k) (Traditional)
- Applicant: Greiner America, Inc.
- Decided: May 2, 1997 after 30 days
- Product code: GIM (Tubes, Vacuum Sample, With Anticoagulant)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have 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) Becton Dickinson's Vacutainer® sodium citrate tube: named in the summary without a submission number

## Most influential descendants
- K992244: Greiner Minicollect Coagulation Blood Collection Tube (1999), 0 descendants of its own

## Recalls of this device
- Aug 8, 2025 · Class II · Z-0408-2026: Blood collection tubes were manufactured with the label applied too high on the tube, which shifted the printed fill level mark upward, which could result in unnecessary sample rejection and repeat co
- Aug 20, 2021 · Class II · Z-2507-2021: Complaint of tubes clotting due to variation of anticoagulant and/or tubes have low vacuum.
- Mar 29, 2021 · Class II · Z-1534-2021: VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% may show insufficient draw volume of the tubes, which could produce erroneous results for prothrombin time, activated partial thromb
- Mar 12, 2020 · Class II · Z-1714-2020: Concerned lot of VACETTE 2mL 9NC Coagulation Tubes were shown to have inconsistent amounts of the 2.3% sodium citrate.
- Jul 2, 2012 · Class II · Z-2154-2012: Part of the lot received a lower concentration of citrate solution which may cause falsely lower values for common coagulation tests.
- Aug 2, 2006 · Not classified · Z-1498-06: Coagulation tubes found with no additive.
- Jul 27, 2004 · Not classified · Z-1331-04: Coagulation tubes may not have received the proper fill of citrate solution.

## Indications for use
The Greiner Vacuette® blood collection tube with sodium citrate is an evacuated blood collection device containing sodium citrate anticoagulant additive and intended for use in evaluations of coagulation analyses.

Source page: https://510kreport.com/device/K971221
Methodology: https://510kreport.com/methodology