Terminated

Abbott CELL-DYN 3500 Hematology Analyzer CS (Closed Sampler), CELL-DYN 3500 SL (Sample Loader). Manufactured by Abbott Diagnostics Division, Santa Clara, Ca Medical Device, hematology analyzer for in vitro diagnostic use in clinical Laboratories.

FDA Recall Z-1703-2011 · Posted 2011-03-17

Recalling FirmAbbott Laboratories

Recall StatusTerminated

Product CodeGKZ

Date Initiated2009-03-27

Date Terminated2011-12-21

Product Quantity2961 units

Reason for Recall

FIRE HAZARD-- Some power supply modules may have incorrect fuses installed, which may result in fires and smoking.

Firm Action

Abbott Laboratories sent Product Correction letters, dated March 22, 2010, to its customers. The letter listed the additional products that are now included in the recall and gave an explanation of the reason for recall. The letter also discussed the safety impact and provided a list of necessary actions for customers. Customers are to check that the ampere rating of the fuse matches the voltage of operation that is currently being utilized with their CELL-DYN 3000 Analyzer. If the fuse is correct, then the steps provided should be followed. If the fuse is incorrect, then customers are to replace the fuse with the correct fuse and follow the instructions provided. Customers are to contact their local Customer Support Representative in the event that they do not have their replacement fuse that was provided with the Accessory Kit. Customers can refer to the Product Information Letter dated April 20, 2010 for additional labeling to assist with the correct fuse replacement. The Customer Reply form should be completed and the letter should be kept with the Operator's Manual. Questions should be directed to Customer Support at 1-877-4ABBOTT. The firm, Abbott Laboratories, sent a "Product Correction" letter dated March 27, 2009 to its customers. The letter included a Customer Reply form and CELL-DYN accessory kits to inform new customers of the necessity of replacing fuses correctly. The letter described the product, problem and actions to be taken. The customers were instructed to check that the ampere rating of the fuse matches the voltage of operation that is currently being utilized with their CELL-DYN 3700 System and follow the instructions provided, and complete and return the Customer Reply form via fax to 1-800-777-0051 or e-mail [email protected], even if they no longer have the instrument. The firm intends to service items in the field. In April 2010, additional labeling was sent to customers providing additional information when replacing fuses.

Root Cause

Component design/selection

Distribution Pattern

Worldwide Distribution -- USA, including states of: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY; and countries of Argentina, Australia, Bahamas, Barbados, Brazil, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Curacao, Dominica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Haiti, Honduras, Hong Kong, Jamaica, Japan, Mexico, New Zealand, Panama, Paraguay, Peru, Puerto Rico, Singapore, South Korea, Taiwan, Thailand Trinidad and Tobago, Turks & Caicos, Uruguay, and Venezuela.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K991605CELL-DYN 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700 SYSTEM WITH IMMATURE RETICULOCYTE FRACTIONAbbott Laboratories · 1999-07-09

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.