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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm May 20, 2005
Date Posted June 28, 2005
Recall Status1 Terminated 3 on November 21, 2005
Recall Number Z-0937-05
Recall Event ID 32164
Product Classification Electrode, Ion Specific, Potassium - Product Code CEM
Product Potassium Electrode Tip;
Part No.s:
668281 Tip Assembly- Synchron Family
669117 Packaged- Synchron Family
441104 Electrode Assembly- EL-ISE
445604 Electrode Packaged- EL-ISE
Code Information Multiple lots are involved.    |SYNCRHON: | | |  |Lot 446 ¿ Manufactured 20 NOV 2004* |231 |N/A** |  |Lot 450 ¿ Manufactured 12 DEC 2004 |880 | |  |Lot 501 ¿ Manufactured 03 JAN 2005 |30 | |  |Lot 504 ¿ Manufactured 24 JAN 2005 |698 | |  |Lot 507 ¿ Manufactured 21 FEB 2005 |400 | |  |Lot 508 ¿ Manufactured 28 FEB 2005 |130 | |  |Lot 512 ¿ Manufactured 28 MAR 2005 |1643 | |  |Lot 517 ¿ Manufactured 02 MAY 2005 |2020 | |  | | | |  |EL-ISE: | | |  |Lot 0446 ¿ Manufactured 20 NOV 2004* |20 |N/A** |  |Lot 0504 ¿ Manufactured 24 JAN 2005 |30 | |  |Lot 0508 ¿ Manufactured 28 FEB 2005 |30 | |  |---------------------------------------------+---------------+---------------------| 
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
For Additional Information Contact Nancy Johnson
714-961-4489
Manufacturer Reason
for Recall		 Does not meet performance criteria and exhibits upward trend of result recoveries during calibration period.
FDA Determined
Cause 2		 Other
Action Firm sent letters by US Mail requesting that users discard thier probes.
Quantity in Commerce 2686
Distribution United States and Canada
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.
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