PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: January 29, 2020 Initiated: November 25, 2019 #Z-0818-2020

Product Description

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.

Details

Units Affected
1,002,000 tubes
Distribution
Nationwide distribution in the states of IL, MO, AZ, NC. PA, UT, NY, ME, PR, VA, PA
Location
Monroe, NC

Frequently Asked Questions

What product was recalled?
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.. Recalled by Greiner Bio-One North America, Inc.. Units affected: 1,002,000 tubes.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 29, 2020. Severity: Moderate. Recall number: Z-0818-2020.