UniCel DxC 880i, 860i and 600i Systems; Software Part Number: A84500, A86646; Software version: 4.9.01 The UniCel Synchr
FDA device recall Z-2590-2010 · posted 2010-09-30 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc.
- Reason for recall
- Beckman Coulter is initiating a recall on their UniCel DxC Clinical Systems (880i, 860i,680i and 660i Systems with serial number <2760 that have software version 4.9.01 installed and have the VME Motorola ICS board) because they may exhibit issues with stat sample rack loading, causing a possible delay in results.
- Action taken
- Beckman Coulter sent an URGENT: FIELD SAFETY NOTICE letter, dated March 25, 2010, to all customers. The letter identified the affected product, the problem, and the actions customers take. Customers were instructed to: if the UniCel DxC system serial number was less than 2760 the customer should contact their local representative to arrange for an upgrade to software version 4.9 build 02. Complete and return the enclosed response form within 10 days of the notice. Share the information with their laboratory staff and retain the notification as part of the Quality System documentation. If affected products were forwarded to another laboratory, provide a copy of the notification letter to them. Customers may contact the Customer Support Center (Hotline) at 1-800-854-3633. For questions or comments please contact the firm at (714) 961-3634
- Root cause
- Other
- Status
- Terminated
- Product code
- JJE
- Quantity affected
- 22
- Distribution
- Class II Recall - USA, including the states of CA, IN, GA, NC, NY, OH, SC, and WI
- Date initiated
- 2010-02-25
- Date posted
- 2010-09-30
- Date terminated
- 2012-07-02
- 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 |