Potassium Electrode Tip; Part No.s: 668281 Tip Assembly- Synchron Family 669117 Packaged- Synchron Family 441104 Electro
FDA device recall Z-0937-05 · posted 2005-06-28 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- Does not meet performance criteria and exhibits upward trend of result recoveries during calibration period.
- Action taken
- Firm sent letters by US Mail requesting that users discard thier probes.
- Root cause
- Other
- Status
- Terminated
- Product code
- CEM
- Quantity affected
- 2686
- Distribution
- United States and Canada
- Date initiated
- 2005-05-20
- Date posted
- 2005-06-28
- Date terminated
- 2005-11-21
- Location
- Brea, CA
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