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

510(k) K960857

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

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)SESE Substantially Equivalent · Traditional	NumberK960857	Date30 Aug 1996Cleared	StatusActive

5 recalls · 1 ongoing · FDA

- Ongoing Z-0200-2027 FDA Not yet classified initiated 29 Jul 2026
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++) results which have the potential to cause hyperkalemia.
- Terminated Z-0502-2022 FDA Class II initiated 9 Dec 2021
Some of the blood collection tubes show clotting due to variation of Lithium Heparin.
- Terminated Z-1081-2012 FDA Unclassified (pre-2012) initiated 14 Dec 2011
The lithium heparin tubes may have a contamination with EDTA potassium.
- Terminated Z-0623-2011 FDA Unclassified (pre-2012) initiated 25 Aug 2010
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.
- Terminated Z-0215-2009 FDA Unclassified (pre-2012) initiated 29 Jul 2008
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 rack label information showed the correct information with 2 ml Lithium Heparin.

1 jurisdiction

United States — FDA 510(k) Active

510(k)