FDA recall Z-0818-2020

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

Product

VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P - Product Usage: VACUETTE Tubes, Holders, and Needles are use together as a system for the collection of venous blood. VACUETTE tubes are used to collect, transport, and process blood for testing serum, plasma, or whole blood in the clinical laboratory.

Reason for recall

The Vacuette 3.5mL Serup Sep Clot Activator Tubes may have been damaged at the cap sealing area. This may lead to a vacuum loss and tubes not filling up to the proper volume.

Distribution

Nationwide distribution in the states of IL, MO, AZ, NC. PA, UT, NY, ME, PR, VA, PA

Key facts

Status
Terminated
Initiation date
2019-11-25
Report date
2020-01-29
Termination date
2020-10-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Monroe, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0818-2020