Z-0361-06

Roche brand Omni S2 Blood Gas Analyzer; Catalog # 03337111001

Name: Z-0361-06 Roche brand Omni S2 Blood Gas Analyzer; Catalog # 03337111001
Creator: Roche Diagnostics Corp.
Published: 2005-12-09
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2005-12-09 / Terminated

FDA source

Roche Diagnostics Corp. began a recall of Roche brand Omni S2 Blood Gas Analyzer; Catalog # 03337111001 on 2005-12-09. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0361-06
Status: Terminated
Initiated: 2005-12-09
Posted: 2006-01-07
Terminated: 2006-04-10
Recalling firm: Roche Diagnostics GmbH
Product: Roche brand Omni S2 Blood Gas Analyzer; Catalog # 03337111001.
Product code: KHG Whole Blood Hemoglobin Determination
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.
FDA root cause: Other
Action: Consignees were notified via letter dated 12/9/05.
Distribution: California, Florida, Georgia, Indiana, Iowa, New Hampshire, Michigan, New York, North Carolina, North Dakota, Pennsylvania, Texas and Washington.
Product codes and lots: All units with Co-Oximetry (COOX) modules.

Product code KHG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)