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U.S. Department of Health and Human Services

Class 2 Device Recall Allegra X5 Centrifuge

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  Class 2 Device Recall Allegra X5 Centrifuge see related information
Date Initiated by Firm February 05, 2016
Create Date July 23, 2016
Recall Status1 Terminated 3 on January 17, 2017
Recall Number Z-2274-2016
Recall Event ID 74567
Product Classification Centrifuges (micro, ultra, refrigerated) for clinical use - Product Code JQC
Product Allegra X-5 rotor yoke, Catalog No. (Instruments) B30589 and B30590 (Rotor) B30593. Product Labeling: IFU B29071AA.

Product Usage:
For In Vitro Diagnostic Use. The Allegra X-5 is intended for the separation of components through the use of relative centrifugal force. It is designed to separate human samples, including blood and other body fluids, for processing, analysis and in vitro diagnostic testing, as well as non-human body samples and chemicals, including industrial and environmental samples. This centrifuge should be operated by qualified personnel only.
Code Information AFB13H005, AFB13H008, AFB13H012, AFB13K002, AFB13K005, AFB13K008, AFB13J002, AFB13J003, AFB13J004, AFB13J005, AFB13J007, AFB15J001, AFB15C010, AFB13K009, AFB14H001, AFB15C008, AFB15C003, AFB15C005, AFB15C004, AFB15C006, AFB14H005, AFB14H003, AFB13K004, AFB13K006, AFB13K007, AFB13J008, AFB13K001, AFB13J006, AFB13J010, AFB13H013, AFB13H009, AFB13H003, AFB13H004
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
Manufacturer Reason
for Recall		 A defective rotor yoke on Allegra X-5 allows improper rotor seating on the hub resulting in possible rotor failure if the buckets are loaded in an imbalanced configuration.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Beckman Coulter sent an Important Product Notice Recall letter dated February 5, 2016 to customer. The letter identified the affected product problem and actions to be taken. Customers are instructed to complete and return the enclosed Response Form. Customers with questions are instructed to contact our Customer Support Center " Via website, http://www.beckmancoulter.com/customersupport/support " Via phone, call 800-369-0333 the United States and Canada " Outside the United States and Canada, contact your local Beckman Coulter Representative.
Quantity in Commerce 62 units total (33 units in US)
Distribution Worldwide Distribution - US Nationwide (including Puerto Rico) and the countries of: Australia, Canada, Colombia, Germany, Guatemala, Netherlands, Singapore, Tunisia, , Spain
Total Product Life Cycle TPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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