—#96251

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.

FDA product code: GKZ — Counter, Differential Cell
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K030408
Affected lot / code info: All lots since 08/2003

Why it was recalled

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.

Root cause (FDA determination)

Pending

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 200 S Kraemer Blvd, Brea, California 92821-6208

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2010-09-16
Posted by FDA: 2011-04-04
Terminated: 2012-06-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #96251. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.