Z-0937-05

Potassium Electrode Tip; Part No.s: 668281 Tip Assembly- Synchron Family 669117 Packaged- Synchron Family...

Name: Z-0937-05 Potassium Electrode Tip; Part No.s: 668281 Tip Assembly- Synchron Family 669117 Packaged- Synchron Family...
Creator: Beckman Coulter Inc
Published: 2005-05-20
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2005-05-20 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc began a recall of Potassium Electrode Tip; Part No.s: 668281 Tip Assembly- Synchron Family 669117 Packaged- Synchron Family 441104 Electrode Assembly- EL-ISE 445604 Electrode... on 2005-05-20. The reason FDA records is "Does not meet performance criteria and exhibits upward trend of result recoveries during calibration period". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0937-05
Status: Terminated
Initiated: 2005-05-20
Posted: 2005-06-28
Terminated: 2005-11-21
Recalling firm: Siemens Healthcare Diagnostics 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
Product code: CEM Electrode, Ion Specific, Potassium
Reason for recall: Does not meet performance criteria and exhibits upward trend of result recoveries during calibration period.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Firm sent letters by US Mail requesting that users discard thier probes.
Quantity in commerce: 2686
Distribution: United States and Canada
Product codes and lots: 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 | | |---------------------------------------------+---------------+---------------------|

Product code CEM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)