Class 2 Device Recall COULTER Ac"T" 5diff Fix Reagent.

• Date Initiated by Firm: April 08, 2011
• Date Posted: May 20, 2011
• Recall Status: Terminated on June 04, 2012
• Recall Number: Z-2231-2011
• Recall Event ID: 58569
• Product Classification: Products, red-cell lysing products - Product Code GGK
• Product: COULTER¿ Ac"T" 5diff Fix Reagent. ; ; Part Number: 8547171; COULTER¿ AC"T" 5diff Fix, Instructions for Use, PN 772264. Intended for use as a leukocyte reagent to differentiate subpopulations of cells on COULTER Ac"T 5diff hematology analyzers. Intended for use only with specific Ac"T 5diff reagents. Refer to the instrument product manuals and/or online help, as applicable.
• Code Information: Lot # 16602E, 16702E, 16802E
• Recalling Firm/ Manufacturer: Beckman Coulter Inc.; 250 S Kraemer Blvd; Brea CA 92821-6232
• 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 confirmed that an issue has been identified with one of the raw materials used to manufacture the Coulter A T 5 diff PN 8547171.
• FDA Determined Cause: Other
• Action: Beckman Coulter initiated a Product Corrective Action (PCA) letter on April 8, 2011, with attached PCA Response Form to all customers who purchased the COULTER¿ Ac"T" 5diff Fix Reagent. The letter provided the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to discard the product according to their laboratory safety procedures and use the attached response form to request replacement product. All flagged results should be reviewed as outlined in the Instructions for Use manual and your laboratory protocol. A retrospective review of results is not required if all recommendations for review have been followed as shown in the Instructions for Use. Customers were instructed to share the information with their laboratory staff and to retain the notification as part of their Quality System documentation. If the product was further distirbuted to another laboratory, customers should provide them a copy of the notification letter. The raw material issue has been corrected beginning with COULTER¿ A T 5diff Fix lot 16902E. Customers were instructed to complete and return the enclosed Response Form within ten (10) days. Customers with any questions concerning this notice, were instructed to contact Beckman Coulter Customer Service at 800-526-7694 in the United States or Canada, or contact their local Beckman Coulter representative.
• Quantity in Commerce: 4662 units total (2278 in US)
• Distribution: Worldwide Distribution - USA (nationwide) and the countries of Algeria, Angola, Australia, Botswana, Bulgaria, Czech Republic, Estonia, Finland, France, Germany, Greece, Guyana, Italy, Japan, Kenya, Mexico, Morocco, Namibia, Netherlands, Nigeria, Philippines, Puerto Rico, Russian Federation, Slovakia, South Africa, Switzerland, Taiwan, United Arab Emirates, United Kingdom, Venezuela, and Zambia
• 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.