Home › Device types › GKR
System, Hemoglobin, Automated
FDA product code GKR · Class 2 · Hematology
236
Registered devices
181
Adverse events
8
Recalls
39
510(k) clearances
Devices with this code
ABL80 SC80 — Radiometer Medical ApSHemoPoint® H2 n•x•t Microcuvettes — STANBIO LABORATORY, L.P.AIMSTRIP HEMOGLOBIN METER — GERMAINE LABORATORIES, INCSTAT PROFILE — NOVA BIOMEDICAL CORPORATIONABL90 FLEX, Clot catcher — Radiometer Medical ApSABL80 SC80 — Radiometer Medical ApSReady Sensor™ GOLD Reference Sensor — Siemens Healthcare Diagnostics Inc.ABL90 FLEX PLUS — Radiometer Medical ApSABL80 SC80 — Radiometer Medical ApSHemoCue® Hb 201 Microcuvettes — Hemocue ABABL80 SC80 — Radiometer Medical ApSRAPIDLab® 1200 Na+/K+/Ca++/CL- Electrode Fill — Siemens Healthcare Diagnostics Inc.RAPIDLab® 1200 Series 1245 — Siemens Healthcare Diagnostics Inc.RAPIDPoint® 405/500 Measurement Cartridge — Siemens Healthcare Diagnostics Inc.ABL80 SC80 — Radiometer Medical ApSHemoCue® Hb 201+ Analyzer — Hemocue ABABL80 SC80 — Radiometer Medical ApSABL80 SC80 — Radiometer Medical ApSABL80 SC80 — Radiometer Medical ApSABL80 FLEX Analyzer — Radiometer Medical ApSSTAT PROFILE — NOVA BIOMEDICAL CORPORATIONStat Profile — NOVA BIOMEDICAL CORPORATION925-047 ABL90 FLEX inlet clip — Radiometer Medical ApSReady Sensor™ GOLD Electrode pCO2 — Siemens Healthcare Diagnostics Inc.
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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