Date Initiated by Firm | May 22, 2012 |
Date Posted | October 10, 2012 |
Recall Status1 |
Terminated 3 on October 10, 2012 |
Recall Number | Z-0035-2013 |
Recall Event ID |
63161 |
510(K)Number | K030828 |
Product Classification |
Counter, differential cell - Product Code GKZ
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Product | TetraCXP Software System, Part Number A40051.
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-PC5. |
Code Information |
All tetraCHROME lots manufactured |
Recalling Firm/ Manufacturer |
Beckman Coulter Inc. 250 S Kraemer Blvd Brea CA 92821-6232
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For Additional Information Contact | Clair K. O'Donovan, Ph.D. 714-961-4483 |
Manufacturer Reason for Recall | The recall was initiated because Beckman Coulter has determined that the specimen and prepared sample stability claims stated in the product labeling for tetraCXP software and CYTO-STAT reagents (CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 and CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5) need to be updated for alignment with current standards and clinical decision-making associated with lymphocyte immunophenotyping |
FDA Determined Cause 2 | Process control |
Action | Beckman Coulter sent a Product Corrective Action (PCA) letter dated May 22, 2012, with attached PCA Response Form to all customers who purchased the tetraCXP Software, CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5. The letter provides the customers with an explanation of the problem identified and actions to be taken. Customers were informed that the tetraCXP SYSTEM Guide and CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 & CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 product labeling will be revised to reflect the updated claims. Customers were instructed to complete and return the enclosed Response form within 10 days. Customers with questions were instructed to contact Beckman Coulter Customer Service at (800) 526-7694 in the US and Canada or contact their local Beckman Coulter representative.
For questions regarding this recall call 714-961-4483. |
Quantity in Commerce | 146 units total (37 units in US) |
Distribution | Worldwide Distribution - USA (nationwide) and the following countries:
Albania
Australia
Austria
Bahrain
Bangladesh
Barbados
Belarus
Belgium
Bosnia and Herzegovina
Bulgaria
Burundi
Canada
Chile
China
Colombia
Croatia
Czech Republic
Denmark
Ecuador
El Salvador
Finland
France
French Guiana
French Polynesia
Germany
Greece
Guadeloupe
Hong Kong
India
Indonesia
Iraq
Ireland
Israel
Italy
Japan
Kenya
Korea, Republic of
Kuwait
Libyan Arab Jamahiriya
Lithuania
Macao
Malaysia
Mexico
Monaco
Morocco
Namibia
Netherlands
New Zealand
Nigeria
Norway
Oman
Pakistan
Panama
Poland
Puerto Rico
Qatar
Reunion
Romania
Russian Federation
Saudi Arabia
Singapore
Slovakia
Slovenia
South Africa
Spain
Sudan
Sweden
Switzerland
Taiwan
Turkey
United Arab Emirates
United Kingdom
Uruguay |
Total Product Life Cycle | TPLC Device Report |
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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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