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Terminated

Roche brand OMNI 8 clinical chemistry analyzer; catalog numbers GD0455 and GD0455R.

FDA Recall Z-0327-04 · Posted 2004-01-10

Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeJJE
Date Initiated2003-12-15
Date Terminated2004-08-02

Reason for Recall

If the sample volume is insufficient, the analyzer may issue erroneous results without any indication to the user that the problem is insufficient sample volume.

Firm Action

Consignees were notified by letter mailed on or about December 15, 2003. Customers are instructed to assure an adequate sample volume until new software becomes available.

Root Cause

Other

Distribution Pattern

United States.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K972733AVL OMNI ANALYZERAvl Scientific Corp. · 1997-09-09

Official Source

View FDA Recall →

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

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