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Terminated

Roche brand OMNI 5 Analyzer; catalog numbers GD0395 and GD0395R.

FDA Recall Z-0333-04 · Posted 2004-07-20

Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeJJE
Date Initiated2003-12-29
Date Terminated2004-02-20

Reason for Recall

The firm is withdrawing claims that pleural, pericardial, ascitic and cerebrospinal fluids are appropriate sample types for use on these instruments.

Firm Action

A recall letter dated 12/29/03 was issued to each customer instructing them not to use the listed sample types.

Root Cause

Other

Distribution Pattern

United States.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K954018AVL OMNI ANALYZERAvl Scientific Corp. · 1995-10-05K945915AVL OMNI ANALYZERAvl Scientific Corp. · 1995-04-05

Official Source

View FDA Recall →

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

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