UniCel DxC 660i The UniCel DxC Integrated Workstation combines a UniCel DxC 600 or UniCel DxC 800 analyzer and a UniCel
FDA device recall Z-2075-2011 · posted 2011-04-26 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc.
- Reason for recall
- This recall was initiated because Beckman Coulter has confirmed that for User-Defined Chemistries (UDRs), the polychrome correction is not automatically updated when wavelengths are modified.
- Action taken
- The firm, Beckman Coulter, sent an "URGENT: PRODUCT CORRECTIVE ACTION (PCA)" letter dated October 20, 2010 with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased Synchron LX and UniCel DxC Clinical Systems Operating Software (all versions). The letter describes the product, problem and actions to be taken. The customers were instructed to do the following: -After modifying any UDR wavelength, they MUST reboot to apply the update of the polychrome correction. -If the modified UDR requires calibration, recalibrate after rebooting. - Complete and return the enclosed RESPONSE FORM within 10 days via fax to (714) 961-4234 or mail to: Beckman Coulter, Inc., Attn: Regulatory Affairs, 250 S. Kraemer Blvd, PO Box 8000, Brea, California, 92282-8000; Mail Code E2.SE.08. In addition, the customers were instructed to share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. If customers forwarded any of the affected product listed above to another laboratory, please provide a copy of this letter to them. If customers have any questions regarding this Product Corrective Action letter, please call Beckman's Customer Support Center (Hotline) at (800) 854-3633 in the United States and Canada or www.beckmancoulter.com/customersupport/supportrequests.
- Root cause
- Environmental control
- Status
- Terminated
- Product code
- CEM
- Quantity affected
- 4879 units total (3490 in US)
- Distribution
- Worldwide distribution: USA (nationwide) and countries including:Angola, Australia, Belgium, Bulgaria, China, Colombia, Costa Rica, Czech Republic, Denmark, Ecuador, Egypt, Eritrea, Finland, France, F
- Date initiated
- 2010-10-22
- Date posted
- 2011-04-26
- Date terminated
- 2014-09-02
- Location
- Brea, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS (K042291) | Beckman Coulter, Inc. | 2004-11-12 |