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U.S. Department of Health and Human Services

Class 2 Device Recall CellDyn

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 Class 2 Device Recall CellDynsee related information
Date Initiated by FirmJune 16, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on August 11, 2004
Recall NumberZ-1112-04
Recall Event ID 29434
Product Classification Counter, Cell, Automated (Particle Counter) - Product Code GKL
ProductCell-Dyn 1000 series platelet analyzer (model numbers 1300, 1400, 1600, 1700, 1800)
Code Information List numbers 91361-01,-03 (CD1300), 91360-03 (CD1300), 91336-01,-03 (CD 1400), 91377-01,-03 (CD 1400 CS), 91338-01, -03 (CD 1400 w/ RS232), 91339-01,-03 (CD 1400 CS w/ RS232) 91373-01, -03 (CD1600 CS 220v), 91375-01,-03 (CD 1600 CS 220v), 91374-01, -03 (CD 1600 CS120v), 91372-01,-03 (CD 1600 CS120v) 03H57-01, -03 (CD 1700 CS), 03H53-01, -03 (CD 1700), 07H77-01 (CD1800)-- 510k: 13/1400: K903665/A, 16/1700: K870233, 1800: K030513
FEI Number 2919069
Recalling Firm/
Manufacturer		 Abbott Laboratories
5440 Patrick Henry Dr
Santa Clara CA 95054-1113
For Additional Information ContactJohn Dean
408-567-3430
Manufacturer Reason
for Recall		Analyzer may generate inaccurate PLT concentration counts which may result in overestimation of true PLT concentration.
FDA Determined
Cause 2		Other
ActionCorrection letters and reply forms sent to clients on June 16, 2004, and a software update for the Cell-Dyn 1700 and 1800 series. An additional page to be inserted into user manuals for older models is included. No software update is planned for the older models.
Quantity in Commercecurrently unknown
DistributionThere are a total of 8107 US accounts, 53 government and 8054 private accounts. There are an unknown number of foreign consignees
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.
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