—#147924

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.

FDA product code: JQC — Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: 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

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern: Worldwide Distribution - US Nationwide (including Puerto Rico) and the countries of: Australia, Canada, Colombia, Germany, Guatemala, Netherlands, Singapore, Tunisia, , Spain

Timeline

Recall initiated: 2016-02-05
Terminated: 2017-01-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #147924. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.