UniCel DxH 800 and DxH 600 Coulter Cellular Analysis System. Catalog No. 629029, B24465, B24802, B68304 (Unicel DxH 800
FDA device recall Z-2732-2016 · posted 2016-09-02 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc.
- Reason for recall
- There is a possibility of specimen misidentification for the stand-alone DxH 800 and DxH 600 where the Primary Identifier is configured to Tube Position ID.
- Action taken
- An Urgent Medical Device Recall letter dated 8/8/16 was sent to all customers who purchased the Unicel DxH 800 and DxH 600 Coulter Cellular Analysis System to inform them that there is a possibility of specimen misidentification for the stand-alone DxH 800 and DxH 600 where the Primary Identifier is configured to Tube Position ID. Customers are instructed to complete and return the enclosed response form within 10 days. Customers with any questions regarding the notice are instructed to contact Customer Support Center: http://www.beckmancoulter.com/customersupport/support; 800-526-7694 in the US and Canada; outside the US and Canada, contact local Beckman Coulter representative.
- Root cause
- Software design
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 5,282 units total (2,877 units in US)
- Distribution
- Affected geographies: Andorra, Australia, Belarus, Belgium, Bosnia and Herzegovina, Brunei Darussalam, Canada, China, Columbia, Croatia, Czech Republic, Egypt, Ecuador, France, Germany, Gibraltar, Gre
- Date initiated
- 2016-08-08
- Date posted
- 2016-09-02
- Date terminated
- 2017-04-29
- Location
- Brea, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM/ UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM (K140911) | Beckman Coulter, Inc. | 2014-09-05 |