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Terminated

Roche/Hitachi K Electrode, a potassium electrode for use with the Roche/Hitachi models 717,747, 902, 911,912, 917, Modular and cobas c 501 clinical chemistry analyzers; Roche Catalog/Part Number 10825441001/ US # 722-4402.

FDA Recall Z-1352-06 · Posted 2006-08-03

Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeCEM
Date Initiated2006-07-14
Date Terminated2007-12-04
Product Quantity1970

Reason for Recall

A design change in the electrodes will result in incorrect potassium level results.

Firm Action

A recall letter dated 7/14/06 instructs users to discontinue use of the product and to discard it.

Root Cause

Other

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K953239BOEHRINGER MANNHEIM/HITACHI 917 ANALYZERBoehringer Mannheim Corp. · 1995-09-25

Official Source

View FDA Recall →

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

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