Recall Z-3027-2020— Greiner Bio-One North America, Inc.

Name: FDA recall Z-3027-2020
Creator: U.S. Food and Drug Administration
Published: 2020-08-28

Class II · Terminated

Class II FDA medical device recall by Greiner Bio-One North America, Inc., initiated 2020-08-28, terminated 2021-06-17. It names one FDA 510(k) clearance: K081929. Product: VACUETTE TUBE 5 mL CAT Serum Separator Clot Activator, Item Number: 456018P - Product Usage: are used to collect, transport, and process blood for testing serum, plasma or whole blood in the clinical laboratory.. Reason: Blood collection tubes experienced an issue with separation and clotting.

Recalling firm: Greiner Bio-One North America, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-08-28
Terminated: 2021-06-17
Firm location: Monroe, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K081929 — VACUETTE BLOOD COLLECTION TUBE WITH CLOT ACTIVATOR AND GEL SEPARATORGreiner Bio-One North America, Inc.·cleared 2008-12-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

VACUETTE TUBE 5 mL CAT Serum Separator Clot Activator, Item Number: 456018P - Product Usage: are used to collect, transport, and process blood for testing serum, plasma or whole blood in the clinical laboratory.

Reason for recall

Blood collection tubes experienced an issue with separation and clotting

Data sourced from openFDA. This site is unofficial and independent of the FDA.