Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0818-2020 — 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 clin

U.S. FDA — Device Enforcement · United States · 2019-11-25 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0818-2020
Date of alert: 2019-11-25
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Greiner Bio-One North America, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 29120049204476

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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