Power Express, REF B90918

FDA device recall Z-2978-2024 · posted 2024-09-05 · Open, Classified

Recall details

Recalling firm

Beckman Coulter Biomedical GmbH

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.

Action taken

On July 18, 2024, Beckman Coulter issued a "Urgent Medical Device Recall" notification to affected consignees. Beckman Coulter asked consignees to take the following actions: 1. follow your laboratory procedure to handle biohazard materials and contact your Beckman Coulter representative for servicing your Power Express system. 2. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected products listed above to another laboratory, please provide them a copy of this letter. 3. respond within 10 days in one of the following ways: . Electronically, if you received this communication via email. . Manually, complete and return the enclosed Response Form. 4. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

CDD

Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Bahrain, Canada, China, Colombia, Egypt, France, Germany, Italy, Jordan, Korea, Kuwait, Lebanon, Malaysia, Panama, Qatar, Russian

Date initiated

2024-07-17

Date posted

2024-09-05

Location

Munchen, Germany

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