COULTER LH 500 Series System
FDA device recall Z-2337-2010 · posted 2010-09-01 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc.
- Reason for recall
- The recall was initiated after Beckman Coulter identified four (4) issues with the COULTER LH 500 Series System and the Unicel DxH 800 Coulter Cellular Analysis System: Issue 1: There is a potential for misidentification to occur when the system is configured in languages other than English or Chinese. The characters #,@,[,\,],`,{,|,}, or ~ are substituted or omitted in other languages. The issu
- Action taken
- The customer recall notification was initiated when Product Corrrective Actions letters with attached Customer Response form were sent on the week of February 15, 2010 to all customers who purchased the COULTER LH 500 Series System and the Unicel DxH 800 Coulter Cellular Analysis System. The letters will provided the customers with an explanation of the problem identified and a work around. Customers with questions regarding the Product Corrective Action were instructed to call 800-526-7694 in the United States or Canada, or contact your local Beckman Coulter Representative.
- Root cause
- Software design
- Status
- Terminated
- Product code
- GKZ
- Quantity affected
- 1373 units in US and 147 units in Canada
- Distribution
- Throughout the United States and Canada
- Date initiated
- 2010-02-12
- Date posted
- 2010-09-01
- Date terminated
- 2010-09-10
- 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 |
|---|---|---|
| COULTER LH 500 HEMATOLOGY ANALYZER (K032000) | Beckman Coulter, Inc. | 2003-08-13 |