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[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,

recall fda device united-states

Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.

Recall details

ProductVACUETTE 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 clin
Brand / manufacturerGreiner Bio-One North America, Inc.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0818-2020
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date25 November 2019
EAN / barcode29120049204476

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Greiner Bio-One North America, Inc.

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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