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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmMay 20, 2005
Date PostedJune 28, 2005
Recall Status1 Terminated 3 on November 21, 2005
Recall NumberZ-0937-05
Recall Event ID 32164
Product Classification Electrode, Ion Specific, Potassium - Product Code CEM
ProductPotassium 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 | |  |---------------------------------------------+---------------+---------------------| 
FEI Number 2050012
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
For Additional Information ContactNancy 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
ActionFirm sent letters by US Mail requesting that users discard thier probes.
Quantity in Commerce2686
DistributionUnited States and Canada
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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