Date Initiated by Firm | February 12, 2010 |
Date Posted | September 01, 2010 |
Recall Status1 |
Terminated 3 on September 10, 2010 |
Recall Number | Z-2337-2010 |
Recall Event ID |
55699 |
510(K)Number | K032000 |
Product Classification |
Counter, Differential Cell - Product Code GKZ
|
Product | COULTER LH 500 Series System |
Code Information |
All serial Numbers. |
Recalling Firm/ Manufacturer |
Beckman Coulter Inc. 200 S Kraemer Blvd Brea CA 92821-6208
|
For Additional Information Contact | Clair K. O'Donovan, Ph.D. 714-961-4483 |
Manufacturer 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 |
FDA Determined Cause 2 | Software design |
Action | 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. |
Quantity in Commerce | 1373 units in US and 147 units in Canada |
Distribution | Throughout the United States and Canada |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = GKZ
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