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
This recall has been terminated (originally issued June 28, 2005).
- Company
- Beckman Coulter Inc.
- Recall Initiated
- May 20, 2005
- Posted
- June 28, 2005
- Terminated
- November 21, 2005
- Recall Number
- Z-0937-05
- Quantity
- 2686
- Firm Location
- Brea, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Does not meet performance criteria and exhibits upward trend of result recoveries during calibration period.
Distribution
United States and Canada
Lot / Code Info
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 | | |---------------------------------------------+---------------+---------------------|
Root Cause
Other
Action Taken
Firm sent letters by US Mail requesting that users discard thier probes.