Date Initiated by Firm |
May 21, 2007 |
Date Posted |
February 06, 2008 |
Recall Status1 |
Terminated 3 on October 15, 2012 |
Recall Number |
Z-0525-2008 |
Recall Event ID |
45918 |
510(K)Number |
K954688
|
Product Classification |
Differential Cell Counter - Product Code GKZ
|
Product |
Beckman Coulter Flow-Count Fluorospheres - Part Number 7547053, Beckman Coulter, Inc., Fullerton, CA 92835 |
Code Information |
Part Number 7547053, Lot Number 754801F |
Recalling Firm/ Manufacturer |
Beckman Coulter Inc 200 S Kraemer Blvd Brea CA 92822-6208
|
For Additional Information Contact |
Nora Zerounian 714-993-3634
|
Manufacturer Reason for Recall |
Sporadic absolute count recovery failures with assayed control cell products when using Lot Number 754801F of the Flow-Count Fluorospheres. Additionally, this lot has experienced secondary fluorescent populations containing more than 20% of the total population, as stated in the Evidence of Deterioration section of the Package Insert.
|
FDA Determined Cause 2 |
Process design |
Action |
A Product Corrective Action (PCA) letter was mailed on May 21, 2007, to all accounts that have ordered Flow-Count Fluorospheres, Part Number 7547053, Lot # 754801F. The letter advised that Beckman Coulter has confirmed absolute count recovery failures with assayed control cell products. Additionally, internal testing has indicated secondary fluorescent populations slightly above their indicated 20% of the total population as stated in the Evidence of Deterioration section of the Package Insert. The letter requests that users immediately discard any bottles of the product and call for a replacement. If no evidence of deterioration has been observed, the firm states that there should not be any negative impact to the results obtained. A response form is included and should be returned to the firm within 10 days. Questions regarding this recall can be addressed by contacting Beckman Coulter Customer Service at 1-800-526-7694. |
Quantity in Commerce |
97 units in the US; 37 units Internationally |
Distribution |
Worldwide Distribution --- including USA and country of Canada. ***CENTER COMMENTS -- The Center requests that the subject recall not be terminated until CDRH has determined that the firm has identified the root cause and performed an adequate CAPA to address the cause of the problem, i.e., quality control.*** |
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.
|
510(K) Database |
510(K)s with Product Code = GKZ and Original Applicant = COULTER CORP.
|