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AIMSTRIP HEMOGLOBIN STARTER KIT 200

GERMAINE LABORATORIES, INC · Model 78200 · UDI-DI 00695684782009

KHGGIG Prescription
10
510(k) clearances
5
Adverse events
1
Recalls
9
Facilities

Description

For testing hemoglobin in whole blood

Recalls

DateFirmReason
2005-12-09Roche 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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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.