Class 3 Device Recall CLAY ADAMS Dynac III Centrifuge

• Date Initiated by Firm: August 17, 2009
• Date Posted: March 11, 2010
• Recall Status: Terminated on April 22, 2010
• Recall Number: Z-1069-2010
• Recall Event ID: 54076
• Product Classification: Cenrifuges (micro, ultra, refrigerated) for clinical use - Product Code JQC
• Product: CLAY ADAMS Dynac III Centrifuge, 120V, Model Number 420104 DYNAC III is a multi-purpose centrifuge, designed for clinical laboratories performing separations in hematology, chemistry, urinalysis, blood banking, microbiology and cytology.
• Code Information: Serial Number: 4510001, 4510002, 4510003, 4510004, 4510005, 4510006, 4510007, 4510008, 4510009, 4510010, 4510011, 4510012, 4510013, 4510014, 4510015, 4510016, 4510017, 4510018, 4510019, 4510020, 4510021, 4510022, 4510023, 4510024, 4510025, 4510026, 4510027, 4510028, 4510029, 4510030, 4510031, 4510032, 4510033, 4510034, 4510035, 4510036, 4510037, 4510038, 4510039, 4510040, 4510041, 4510042, 4510043, 4510044, 4510045, 4510046, 4510047, 4510048, 4510049, 4510050, 4510051, 4510052, 4510053, 4510054, 4510055, 4510056, 4510057, 4510058, 4510059, 4510060, 4510061, 4510062, 4510063, 4510064, 4510065, 4510066, 4510067, 4510068, 4510069, 4510070, 4510071, 4510072, 4510073, 4510074, 4510075, 4510076, 4510077, 4510078, 4510079, 4510080, 4510081, 4510082, 4510083, 4510084, 4510085, 4510086, 4510087, 4510088, 4510089, 4510090, 4510091, 4510092, 4510093, 4510094, 4510095, 4510096, 4510097, 4510098, 4510099, 4510100, 4510101, 4510102, 4510103, 4510104, 4510105, 4510106, 4510107, 4510108, 4510109, 4510110, 4510111, 4510112, 4510113, 4510114, 4510115, 4510116, 4510117, 4510118, 4510119, 4510120, 4520001, 4520002, 4520003, 4520004, 4520005, 4520006, 4520007, 4520008, 4520009, 4520010, 4520011, 4520012, 4520013, 4520014, 4520015, 4520016, 4530001, 4530002, 4530003, 4530004, 4530005, 4530006, 4530007, 4530008, 4530009, 4530010, 4530011, 4530012, 4530013, 4530014, 4530015, 4530016, 4530017, 4530018, 4530019, 4530020, 4540001, 4540002, 4540003, 4540004, 4540005, 4540006, 4540007, 4540008, 4540009, 4540010, 4540011, 4540012, 4540013, 4540014, 4540015, 4540016, 4540017, 4540018, 4540019, 4540020, 4540021, 4540022, 4540023, 4540024, 4540025, 4540026, 4540027, 4540028, 4540029, 4540030, 4540031, 4540032, 4540033, 4540034, 4540035, 4540036, 4540037, 4540038, 4540039, 4540040, 4540041, 4540042, 4540043, 4540044, 4540045, 4540046, 4540047, 4540048, 4540049, 4540050, 4540051, 4540052, 4540053, 4540054, 4540055, 4540056, 4540057, 4540058, 4540059, 4540060, 4540061, 4540062, 4540063, 4540064, 4540065, 4540066, 4540067, 4540068, 4540069, 4540070, 4540071, 4540072, 4540073, 4540074, 4550001, 4550002, 4550003, 4550004, 4550005, 4550006, 4550007, 4550008, 4550009, 4550010, 4550011, 4550012, 4550013, 4550014, 4550015, 4550016, 4560001, 4560002, 4560003, 4560004, 4560005, 4560006, 4560007, 4560008, 4560009, 4560010, 4560011, 4560012, 4560013, 4560014, 4560015, 4560016, 4570001, 4570002, 4570003, 4570004, 4570005, 4570006, 4570007, 4570008, 4570009, 4570010, 4570011, 4570012, 4570013, 4570014, 4570015, 4570016, 4570017, 4570018, 4570019, 4570020, 4570021, 4570022, 4570023, 4570024, 4570025, 4570026, 4570027, 4570028, 4570029, 4570030, 4570031, 4570032, 4570033, 4570034, 4570035, 4570036, 4570037, 4570038, 4570039, 4570040, 4570041, 4570042, 4570043, 4570044, 4570045, 4570046, 4570047, 4570048, 4580001, 4580002, 4580003, 4580004, 4580005, 4580006, 4580007, 4580008, 4580009, 4580010, 4580011, 4580012, 4580013, 4580014, 4580015, 4580016, 4580017, 4580018, 4580019, 4580020, 4580021, 4580022, 4580023, 4580024, 4580025, 4580026, 4580027, 4580028, 4580029, 4580030, 4580031, 4580032, 4590001, 4590002, 4590003, 4590004, 4590005, 4590006, 4590007, 4590008, 4590009, 4590010, 4590011, 4590012, 4590013, 4590014, 4590015, 4590016, 4590017, 4590018, 4590019, 4590020, 4590021, 4590022, 4590023, 4590024, 4590025, 4590026, 4590027, 4590028, 4590029, 4590030, 4590031, 4590032, 4590033, 4590034, 4590035, 4590036, 4590037, 4590038, 4590039, 4590040, 4600001, 4600002, 4600003, 4600004, 4600005, 4600006, 4600007, 4600008, 4600009, 4600010, 4600011, 4600012, 4600013, 4600014, 4600015, 4600016, 4600017, 4600018, 4600019, 4600020, 4600021, 4600022, 4600023, 4600024, 4610001, 4610002, 4610005, 4610006, 4610008
• FEI Number: 1119779
• Recalling Firm/ Manufacturer: Becton Dickinson & Co.; 7 Loveton Cir; Sparks MD 21152-9212
• For Additional Information Contact: Kimberly Cartier; 410-316-4000
• Manufacturer Reason for Recall: Medical laboratory centrifuge component may have been assembled incorrectly and cause disabling of the safety feature which prevents customers from opening the centrifuge while it is spinning.
• FDA Determined Cause: Nonconforming Material/Component
• Action: An "Urgent Product Recall" letter dated August 2009 was sent to the customers. The letter described the affected product, problem and the action to be taken by customers. The customers were advised to discontinue use of the centrifuge for repair or replacement with refurbished unit , provide an Excel file or a list with name, address and telephone number of end-users who were shipped this product from their distribution branches so that BD may inform them of the issue,and return the enclosed response form. For further assistance regarding product replacement and returns contact our Technical Services Department at 1-800-638-8663.
• Quantity in Commerce: 411 units
• Distribution: Worldwide distribution: USA and Mexico, Phillipines, Columbia, Chile, Ecuador, Venezuela, Puerto Rico, Canada and Singapore.
• 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.