PE Centrifuge Temperature Controlled, REF: B36366, a component of the Power Express.
Summary
The FDA issued a Class II for PE Centrifuge Temperature Controlled, REF: B36366, a component of the Power Expr by Beckman Coulter Biomedical GmbH. 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 en.
Details
Source
Device Recall
External ID
Z-2980-2024
Action Date
2024-09-11
Status
Ongoing
Category
device
Product Description
PE Centrifuge Temperature Controlled, REF: B36366, a component of the Power Express.
Lot/Code Info: UDI: (01)15099590673567/ All serial numbers
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.
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 Federation, Saudi Arabia, Singapore, Spain, Taiwan, Thailand, Turkey, United Arab Amirates, United Kingdom, Vietnam.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-07-17
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 363 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Beckman Coulter Biomedical GmbH has 5 FDA actions in our database, including 5 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Beckman Coulter Biomedical GmbH) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Beckman Coulter Biomedical GmbH have FDA actions?
Beckman Coulter Biomedical GmbH has 5 FDA actions in our database, including 5 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2980-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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