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U.S. Department of Health and Human Services

Class 2 Device Recall CYTOSTAT tetraCHROME CD45FITC/CD56RD1/CD19ECD/CD3PC5

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  Class 2 Device Recall CYTOSTAT tetraCHROME CD45FITC/CD56RD1/CD19ECD/CD3PC5 see related information
Date Initiated by Firm September 16, 2010
Date Posted April 04, 2011
Recall Status1 Terminated 3 on June 14, 2012
Recall Number Z-1877-2011
Recall Event ID 57445
510(K)Number K030408  
Product Classification Differential Cell Counter - Product Code GKZ
Product CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5, Part Number: 6607073.

Allows simultaneous identification and enumeration of total CD3+, total CD4+, total CD8+, dual CD3+/CD4+, dual CD3+/CD8+ and/or total CD3+, CD19+ and CD3-/CD56+ lymphocyte percentages and absolute counts in whole blood by flow cytometry. The systems also provide the CD4/CD8 ratio when using CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, and total lymphocyte percentage when using CD45-FITC/CD56-RD1/ CD19-ECD/CD3-PC5Al.
Code Information All lots since 08/2003
Recalling Firm/
Manufacturer
Beckman Coulter Inc.
200 S Kraemer Blvd
Brea CA 92821-6208
For Additional Information Contact
714-993-5321
Manufacturer Reason
for Recall
A labeling error resulted in the specimen age stability and the prepared sample stability being stated incorrectly in the instructions for use. There is no impact to the product safety or functionality.
FDA Determined
Cause 2
Pending
Action An Urgent: Product Corrective Action letter dated, September 27, 2010, was sent to customers. The letter identified the affected product and stated the reasons for the recall. Customers were also asked to take the following actions: ACTION/RESOLUTION For issue 1: The specimen stability claims should be as follows: - 48 hours for both % positives and absolute counts for the CD45/4/8/3 tube - 24 hours for both % positives and absolute counts for the CD45/56/19/3 tube For Issue 2: Results produced are not impacted when samples are prepared and run within the post collection time frames provided in the product instructions for use: - Preparation within 72 hours of collection for the CD45/4/8/3 tube - Preparation within 24 hours of collection for CD45/56/19/3 tube Beckman Coulter requested consignees complete and return the enclosed response form within 10 days so they may maintain their records. The firm also asked that they share the information with laboratory staff, and retain this notification as part of their Quality System documentation. Questions regarding the Product Corrective Action were directed to (800) 526-7694 in the United States or (800) 463-7828 in Canada. If outside the US or Canada, consignees were instructed to contact their local Beckman Coulter Representative.
Quantity in Commerce 26822 units
Distribution Worldwide Distribution -- United States, Albania, Australia, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Bosnia and Herzegovina, Bulgaria, Burundi, Cameroon, Chile, China, Colombia, Croatia, Czech Republic, Denmark, El Salvador, Finland, France, French Guiana, French Polynesia, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Republic of Kuwait, Libyan Arab Jamahiriya, Macao, Malaysia, Mexico, Monaco, Morocco, Namibia, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan Panama, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sudan, Sweden, Switzerland, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Uruguay.
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 = BECKMAN COULTER, INC.
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