Recall Z-2980-2024— Beckman Coulter Biomedical GmbH

Name: FDA recall Z-2980-2024
Creator: U.S. Food and Drug Administration
Published: 2024-07-17

Class II · Ongoing

Class II FDA medical device recall by Beckman Coulter Biomedical GmbH, initiated 2024-07-17. It names one FDA 510(k) clearance: K140496. Product: PE Centrifuge Temperature Controlled, REF: B36366, a component of the Power Express.. Reason: 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..

Recalling firm: Beckman Coulter Biomedical GmbH
Classification: Class II
Status: Ongoing
Initiated: 2024-07-17
Firm location: Munchen, Germany

510(k) clearances named in this recall

1 on FDA's record

K140496 — Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System ReagentsBeckman Coulter, Inc.·cleared 2014-09-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

PE Centrifuge Temperature Controlled, REF: B36366, a component of the Power Express.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.