—#39279

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

FDA product code: CEM — Electrode, Ion Specific, Potassium
Device class: Class 2
Medical specialty: Clinical Chemistry
Affected 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 | | |---------------------------------------------+---------------+---------------------|

Why it was recalled

Does not meet performance criteria and exhibits upward trend of result recoveries during calibration period.

Root cause (FDA determination)

Other

Action the firm took

Firm sent letters by US Mail requesting that users discard thier probes.

Recalling firm

Firm: Beckman Coulter Inc
Address: 200 S Kraemer Blvd, Brea, California 92822-6208

Distribution

Distribution pattern: United States and Canada

Timeline

Recall initiated: 2005-05-20
Posted by FDA: 2005-06-28
Terminated: 2005-11-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #39279. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.