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Terminated

Roche brand Omni S4 Blood Gas Analyzer; Catalog # 03337138001.

FDA Recall Z-0362-06 · Posted 2006-01-07

Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeCGA
Date Initiated2005-12-09
Date Terminated2006-04-10

Reason for Recall

Potential for hemoglobin derivatives which are outside of the quality control (QC) limits to not engage the auto lock out feature of the system for 02Hb, COHb, HHb, MetHb or SO2.

Firm Action

Consignees were notified via letter dated 12/9/05.

Root Cause

Other

Distribution Pattern

California, Florida, Georgia, Indiana, Iowa, New Hampshire, Michigan, New York, North Carolina, North Dakota, Pennsylvania, Texas and Washington.

Official Source

View FDA Recall →

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

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