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

Recall Z-2978-2024 — Power Express, REF B90918

U.S. FDA — Device Enforcement · Germany · 2024-07-17 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2978-2024
Date of alert
2024-07-17
Country / jurisdiction
Germany
Risk level
Class II
Risk type
recall
Brand
Beckman Coulter Biomedical GmbH
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
15099590681555
Reported risk: The adhesive joint between the plastic socket and metal component of the Power Express Sample Holder can fail, causing the metal part to detach and enter the centrifuge. This detachment can result in damage to the centrifuge and potential destruction of the patient sample resulting in delayed results and possible exposure of lab technician to biohazardous material.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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.