Class 2 Device Recall GLU Reagent

• Date Initiated by Firm: August 10, 2010
• Date Posted: March 09, 2011
• Recall Status: Terminated on October 17, 2013
• Recall Number: Z-1619-2011
• Recall Event ID: 56746
• 510(K)Number: K042291 K060256 K965240 K023049 K011213 K883181
• Product Classification: Glucose oxidase, glucose - Product Code CEM
• Product: GLU Reagent (GLU cartridge assay) used on Synchron LX and UniCel DxC Synchron Clinical Systems, Part Number 442640; ; ; SYNCHRON and UniCel Systems and Part Numbers:; Synchron LX20, Part Number: 466200,; Synchron LX20 PRO, Part Number: 476100,; Synchron LXI 725, Part Number: 476501,; UniCel DxC 600, Part Number: A10405,; UniCel 600 PRO, Part Number: A11810,; UniCel DxC 600i, Part Number: A27318,; UniCel DxC 800, Part Number: A11816,; UniCel DxC 800 PRO, Part Number: A11812,; UniCel DxC 880i, Part Number: A59102,; UniCel DxC 660i, Part Number: A64871,; UniCel DxC 680i, Part Number: A64903,; UniCel DxC860i, Part Number: A64935; ; (1) The Synchron LX and UniCel DxC Synchron Clinical Systems are fully automated, computer controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (Sample type is chemistry dependent). (2) GLUCm reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems AQUA CAL 1 and 2, is intended for the quantitative determination of Glucose concentration in human serum, plasma, urine or cerebrospinal fluid (CSF).
• Code Information: All non-expired lots
• Recalling Firm/ Manufacturer: Beckman Coulter Inc.; 200 S Kraemer Blvd; Brea CA 92821-6208
• For Additional Information Contact: Clair K. ODonovan, Ph.D.; 714-961-4483
• Manufacturer Reason for Recall: The recall was initiated because Cartridge Glucose (GLU) on UniCel DxC and Synchron LX instruments may give falsely high results for moderately hemolysed samples. The Impact: (1) Neonatal samples drawn by lancets are more likely to be hemolysed to a degree sufficient to cause interference with glucose estimation and are a special at-risk population, (2) Other hemolysed samples may be similar
• FDA Determined Cause: Other
• Action: The firm, Beckman Coulter, sent an "URGENT: PRODUCT CORRECTIVE ACTION" letter dated August 10, 2010 with an enclosed fax-back Customer Response Form to the customers. The letter provided the customers with an explanation of the problem identified, the impact and an action to be taken. The customers were instructed to run samples using another method/technology and to complete and return the enclosed FAX BACK RESPONSE FORM via fax to (714) 961-4232 or mail to: Beckman Coulter, Inc., Attn: Regulatory Affairs, 250 S. Kraemer Blvd., PO Box 8000, Brea, CA 92822. Firms with questions regarding this Product Corrective Action letter, were instructed to call our Customer Support Center (Hotline) at (800) 854-3633 in the United States and Canada http://www.beckmancoulter.com/customersupport/support/default.asp.
• Quantity in Commerce: 81,871 units
• Distribution: Worldwide distribution: USA and country: Canada.
• 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.

• 510(K) Database: 510(K)s with Product Code = CEM and Original Applicant = BECKMAN COULTER, INC.; 510(K)s with Product Code = CEM and Original Applicant = BECKMAN INSTRUMENTS, INC.