FDA recall Z-3027-2020

Greiner Bio-One North America, Inc. · Class II · device

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 for recall

Blood collection tubes experienced an issue with separation and clotting

Distribution

US Nationwide distribution including in the states of IL, PA, VA, MO, NY.

Key facts

Status
Terminated
Initiation date
2020-08-28
Report date
2020-10-07
Termination date
2021-06-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Monroe, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3027-2020