—#43254

Product

Roche brand Omni S6 Blood Gas Analyzer; Catalog # 03337154001.

FDA product code: CGA — Glucose Oxidase, Glucose
Device class: Class 2
Medical specialty: Clinical Chemistry
Affected lot / code info: All units with Co-Oximetry (COOX) modules.

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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

Recalling firm

Firm: Roche Diagnostics Corp.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

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

Timeline

Recall initiated: 2005-12-09
Posted by FDA: 2006-01-07
Terminated: 2006-04-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #43254. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.