# K960857: Greiner Vacuette Blood Collection Tube W/Lithium Heparin & Gel Separator

- Pathway: 510(k) (Traditional)
- Applicant: Greiner America, Inc.
- Decided: Aug 30, 1996 after 182 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K944566 (1994). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944566: Vacutainer Brand Plus Sodium Heparin Tube, Bd Becton Dickinson Vacutainer Systems Preanalytic (1994) Summary page 1.

## Most influential descendants
- K011699: Vacuette Evacuated Blood Collection Tubes (2001), 0 descendants of its own

## Recalls of this device
- Jul 29, 2026 · Class II · Z-0200-2027: Lot B26043FM may include EDTA contamination which introduces potassium while chelating calcium in patient samples, leading to falsely elevated potassium (K+) and falsely decreased calcium (Ca++) resul
- Dec 9, 2021 · Class II · Z-0502-2022: Some of the blood collection tubes show clotting due to variation of Lithium Heparin.
- Dec 14, 2011 · Not classified · Z-1081-2012: The lithium heparin tubes may have a contamination with EDTA potassium.
- Aug 25, 2010 · Not classified · Z-0623-2011: Lithium heparin solution was contaminated by EDTA K (potassium) solution due to an operator error and a misinterpretation of a test result. Contaminated tubes will produce inaccurate test results.
- Jul 29, 2008 · Not classified · Z-0215-2009: Labeling Error: Incorrect tube label reads "Z Serum Clot Activator" instead of "LH Lithium Heparin" tube. All other information on the tube label including color coding of tube was correct. Case and r

## Indications for use
The product is intended for use in holding and separating blood plasma from the cellular components of blood.

Source page: https://510kreport.com/device/K960857
Methodology: https://510kreport.com/methodology