Recall Z-2375-2024— Greiner Bio-One North America, Inc.
Class II · Ongoing
Class II FDA medical device recall by Greiner Bio-One North America, Inc., initiated 2024-05-14. It names 3 FDA 510(k) clearances: K081929, K983952, K960858. Product: VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged. Reason: The firm received reports that some blood collection tubes have experienced issues with clotting and poor separation due to missing additive. The failure of the device would likely require sample recollection which could result in a delay of treatment..
- Recalling firm
- Greiner Bio-One North America, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-05-14
- Firm location
- Monroe, NC, United States
510(k) clearances named in this recall
3 on FDA's record- K081929 — VACUETTE BLOOD COLLECTION TUBE WITH CLOT ACTIVATOR AND GEL SEPARATOR
- K983952 — GREINER VACUETTE BLOOD COLLECTION TUBE
- K960858 — GREINER VACUTTE BLOOD COLLECTION TUBE W/ CLOT ACTIVATOR & GEL SEPARATOR
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 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged
Reason for recall
The firm received reports that some blood collection tubes have experienced issues with clotting and poor separation due to missing additive. The failure of the device would likely require sample recollection which could result in a delay of treatment.
Data sourced from openFDA. This site is unofficial and independent of the FDA.