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U.S. Department of Health and Human Services

Class 2 Device Recall CellDyn 3500 System with Immature Reticulocyte Fraction (IRF)

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 Class 2 Device Recall CellDyn 3500 System with Immature Reticulocyte Fraction (IRF)see related information
Date Initiated by FirmMarch 15, 2011
Date PostedApril 29, 2011
Recall Status1 Terminated 3 on November 22, 2011
Recall NumberZ-2016-2011
Recall Event ID 58188
510(K)NumberK991605 
Product Classification Differential Cell Counter - Product Code GKZ
ProductCELL-DYN Shear Valve Assembly used on CELL-DYN 3500SL Analyzer and CELL-DYN 3500SL Analyzer (refurb). Abbott Diagnostics Division, Santa Clara, CA 05054 Designed for in vitro diagnostic use in clinical laboratories.
Code Information List Number 91350-01; lot numbers: 31222P, 32091P Refurbished list number: 91350-03; lot number: 32159P96
Recalling Firm/
Manufacturer		 Abbott Laboratories
5440 Patrick Henry Dr
Santa Clara CA 95054-1113
For Additional Information ContactKelly E. Duffy
408-567-3560
Manufacturer Reason
for Recall		The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient results.
FDA Determined
Cause 2		Pending
ActionProduct Correction letters were sent on March 15, 2011. via Federal Express. The letter identified the affected product, explained the problem, the patient impact and the necessary action that were to be taken. Customers were to review the letter and inform their Laboratory Manager of the pending action.; complete and return the Customer Reply Form; and save a copy of the letter for their records. If there were any questions, customers were to contact Customer Support at 1-877-4ABBOTT or their local hematology customer support representative for customers outside of the US.
Quantity in Commerce174 instruments total, all varieties
DistributionWorldwide Distribution -- AZ, CA, FL, IA, ID, IN, MA, MI, MN, MS, ND, NY, OK, OR, SC, SD, TX, WI, WY and Germany, Singapore, Mexico, China, South Korea, Argentina, Japan, Brazil, Canada, Australia, and Chile.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GKZ
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