FDA Device

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

Hazard

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

What You Should Do

Remedy

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

Products

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
UPC
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 | |  |---------------------------------------------+---------------+---------------------|

Units Affected

2686