UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems, Part Numbers: A64871, A64903, A64935, A59102. The UniCel DxI I
FDA device recall Z-0347-2013 · posted 2012-11-19 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc.
- Reason for recall
- The recall was initiated because Beckman Coulter has confirmed that the UniCel Dxl and DxC Access Immunoassay Systems had field modifications to the aspirate and dispense probe assemblies.
- Action taken
- Beckman Coulter sent a field modification was released in August 2011 which included: - Installing a new aspirate and dispense tubing routing bracket. - Replacing existing aspirate and dispense probe tubing with modified tubing to help eliminatemisrouting of aspirate and dispense probe tubing. During installation the FSE informed the customer: -That aspirate and dispense tubing are different lengths. - That probes are not interchangeable with other instruments once tubing has been modified. - To route probe tubing by referring to the labels on the tubing. An updated service document, Routine Maintenance Changes, A82294B was provided to every customer. For questions regarding this recall call 714-961-4483.
- Root cause
- Process design
- Status
- Terminated
- Product code
- CEM
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Canada, AE, AU, BG, BW, CH, CN, CZ, DE, ES, FR, GB, HK, HR, HU, IN, IT, JO, JP, LB, MA, MX, NL, PL, QA, RO, RU, SK, TN, TR, ZA, AO, AR,
- Date initiated
- 2011-08-01
- Date posted
- 2012-11-19
- Date terminated
- 2012-11-19
- Location
- Brea, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS (K042291) | Beckman Coulter, Inc. | 2004-11-12 |