Home › Device types › GKR
System, Hemoglobin, Automated
FDA product code GKR · Class 2 · Hematology
226
Registered devices
181
Adverse events
8
Recalls
39
510(k) clearances
Devices with this code
Ready Sensor™ GOLD Electrode pCO2 — Siemens Healthcare Diagnostics Inc.ABL80 SC80 — Radiometer Medical ApSABL80 SC80 — Radiometer Medical ApSMission Plus Hemoglobin (Hb) Test Cartridges — Acon Laboratories, Inc.hemochroma PLUS Optical System Check — Immunostics Company, IncHenry Schein — HENRY SCHEIN, INC.STAT PROFILE — NOVA BIOMEDICAL CORPORATIONABL80 SC80 — Radiometer Medical ApSABL80 SC80 — Radiometer Medical ApSABL80 SC80 — Radiometer Medical ApSHemo Control — EKF-diagnostic GmbHRAPIDPoint® 400 Measurement Cartridge — Siemens Healthcare Diagnostics Inc.AIMSTRIP HEMOGLOBIN TEST CARTRIDGES — GERMAINE LABORATORIES, INCABL80 SC80 — Radiometer Medical ApSABL80 SC80 — Radiometer Medical ApSHemo Control Hemoglobin Microcuvette — EKF-diagnostic GmbHStat Profile — NOVA BIOMEDICAL CORPORATIONSTAT PROFILE — NOVA BIOMEDICAL CORPORATIONSTAT PROFILE — NOVA BIOMEDICAL CORPORATIONHemoCue® Hb 201 Microcuvettes — Hemocue ABABL80 SC80 — Radiometer Medical ApSMcKesson — MCKESSON MEDICAL-SURGICAL INC.STAT PROFILE — NOVA BIOMEDICAL CORPORATIONABL90 FLEX Analyzer — Radiometer Medical ApS
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-07-16 | Siemens Healthcare Diagnostics, Inc. | Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the CO-Ox fractions that are reported on the RAPIDPoint and RAPIDL |
| 2018-07-16 | Siemens Healthcare Diagnostics, Inc. | Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the CO-Ox fractions that are reported on the RAPIDPoint and RAPIDL |
| 2018-07-16 | Siemens Healthcare Diagnostics, Inc. | Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the CO-Ox fractions that are reported on the RAPIDPoint and RAPIDL |
| 2018-07-16 | Siemens Healthcare Diagnostics, Inc. | Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the CO-Ox fractions that are reported on the RAPIDPoint and RAPIDL |
| 2018-02-08 | Stanbio Laboratory, LP | The US prong (type A) adapter plate may crack, break, or detach and remain in the electrical outlet exposing live electrical contacts. |
| 2013-07-25 | HemoCue AB | HemoCue AB has become aware of a production related problem involving punctured HemoCue Hb 201 Microcuvettes single pack pouches. |
| 2011-01-21 | ITC-Nexus Dx, Inc. | ITC has determined that results obtained using certain lots of Hgb Pro Professional Hemoglobin Test Strips may differ from results obtained using a reference he |
| 2010-10-07 | Hemo Cue, Inc. | Incorrect configurations settings in software. As a result, certain error codes do not trigger appropriately. These error codes are: E01, E02 and E05 which ar |
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