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U.S. Department of Health and Human Services

Class 2 Device Recall PE Centrifuge

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 Class 2 Device Recall PE Centrifugesee related information
Date Initiated by FirmJuly 17, 2024
Date PostedSeptember 05, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2979-2024
Recall Event ID 95064
510(K)NumberK140496 
Product Classification Radioassay, vitamin b12 - Product Code CDD
ProductPE Centrifuge, REF: B36365, a component of the Power Express
Code Information UDI: (01)15099590673550/ All serial numbers Lots
FEI Number 3006677029
Recalling Firm/
Manufacturer		 Beckman Coulter Biomedical GmbH
Sauerbruchstr. 50
Munchen Germany
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn 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.
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = CDD
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