FDA Medical Device Recalls (openFDA)
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 number
- Z-0937-05
- Recalling firm
- Beckman Coulter Inc
- 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
- Status
- Terminated
- Initiated
- 2005-05-20
- Posted
- 2005-06-28
- Terminated
- 2005-11-21
- Reason
- Does not meet performance criteria and exhibits upward trend of result recoveries during calibration period.
- Root cause
- Other
- Action
- Firm sent letters by US Mail requesting that users discard thier probes.
- Quantity
- 2686
- Distribution
- United States and Canada
- Lot, serial or model codes
- 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 | | |---------------------------------------------+---------------+---------------------|
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CEM
- Firm FEI
- 2050012
- Firm city
- Brea
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28