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Terminated

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 Recall Z-0937-05 · Posted 2005-06-28

Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeCEM
Date Initiated2005-05-20
Date Terminated2005-11-21
Product Quantity2686

Reason for Recall

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

Firm Action

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

Root Cause

Other

Distribution Pattern

United States and Canada

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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