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STAT-Site M Hgb Cards

STANBIO LABORATORY, L.P. · Model 901025 · UDI-DI 00657498000151

KHG Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The Stanbio STAT-Site® MHgb Test Kit is intended for the quantitative determination of hemoglobin in whole blood using the Stanbio STAT-Site® MHgb Meter. The STAT-Site® MHgb Test may be used with adults, infants, and children in a physician’s office or other professional point-of-care setting.

Recalls

Date	Firm	Reason
2005-12-09	Roche Diagnostics Corp.	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.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.