Beckman Coulter Inc 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Beckman Coulter Inc
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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 | | |---------------------------------------------+---------------+---------------------|
Beckman Coulter Inc is recalling Potassium Electrode Tip; Part No.s: 668281 Tip Assembly- Synchron Family 669117 Packaged- Synchron F due to Does not meet performance criteria and exhibits upward trend of result recoveries during calibration period.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Does not meet performance criteria and exhibits upward trend of result recoveries during calibration period.
Recommended Action
Per FDA guidance
Firm sent letters by US Mail requesting that users discard thier probes.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026