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).
FDA Recall Z-1619-2011 · Posted 2011-03-09
Recalling FirmBeckman Coulter Inc.
Recall StatusTerminated
Product CodeCEM
Date Initiated2010-08-10
Date Terminated2013-10-17
Product Quantity81,871 units
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
Firm 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.
Root Cause
Other
Distribution Pattern
Worldwide distribution: USA and country: Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
K060256UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEMBeckman Coulter, Inc. · 2006-02-27K042291UNICEL DXC 600 AND 800 SYNCHRON SYSTEMSBeckman Coulter, Inc. · 2004-11-12K023049SYNCHRON LX I 725 CLINICAL SYSTEMBeckman Coulter, Inc. · 2002-10-04K011213MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEMBeckman Coulter, Inc. · 2001-05-16K965240SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON LBeckman Instruments, Inc. · 1997-03-10K883181SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGEBeckman Instruments, Inc. · 1988-09-19
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.