GLU Reagent (GLU cartridge assay) used on Synchron LX and UniCel DxC Synchron Clinical Systems, Part Number 442640; SYNC
FDA device recall Z-1619-2011 · posted 2011-03-09 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc.
- 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
- Action taken
- 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
- Status
- Terminated
- Product code
- CEM
- Quantity affected
- 81,871 units
- Distribution
- Worldwide distribution: USA and country: Canada.
- Date initiated
- 2010-08-10
- Date posted
- 2011-03-09
- Date terminated
- 2013-10-17
- Location
- Brea, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM (K060256) | Beckman Coulter, Inc. | 2006-02-27 |
| UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS (K042291) | Beckman Coulter, Inc. | 2004-11-12 |
| SYNCHRON LX I 725 CLINICAL SYSTEM (K023049) | Beckman Coulter, Inc. | 2002-10-04 |
| MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM (K011213) | Beckman Coulter, Inc. | 2001-05-16 |
| SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON L (K965240) | Beckman Instruments, Inc. | 1997-03-10 |
| SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGE (K883181) | Beckman Instruments, Inc. | 1988-09-19 |