GLUCm used on Synchron LX and UniCel DxC Synchron Clinical Systems, Part Number: 472500 ( ynchron LX20, LX20 PRO, LXI 72
FDA device recall Z-2388-2010 · posted 2010-09-09 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc.
- Reason for recall
- UniCel DxC and Synchron LX instruments produced inaccurate (low) GLUCm results. False low results could affect or delay diagnosis or treatment.
- Action taken
- Beckman Coulter issued an "Urgent: Product Corrective Action" (PCA) letter dated April 2010 to all consignees, identifying the reason for the recall, the affected lots, and the potential for inaccurate GLUCm results due to bubble retention and short samples. Customers were instructed to: 1) establish specific protocols for samples from defined patient populations or sample types, which could include running specimens using GLUCm in duplicate or using cartridge glucose. 2) To reduce the possibility of inaccurate results, ensure that all elements are properly installed and secured, the sample probe is adequately tightened, and proper sample volume and integrity are maintained. A copy of the PCA letter will also be included in all new instrument ship kits. Consignees were instructed to complete and return an enclosed response form. Consignees can contact Beckman Coulter at 1-973-956-5300 .
- Root cause
- Other
- Status
- Terminated
- Product code
- CGA
- Quantity affected
- 84,186 units (79,071 in US & 5,115 in Canada)
- Distribution
- Worldwide Distribution: USA and Canada
- Date initiated
- 2010-04-15
- Date posted
- 2010-09-09
- Date terminated
- 2013-12-31
- 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 |