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HemoPoint H2
STANBIO LABORATORY, L.P. · Model G3000-CONTCUV · UDI-DI 00657498300039
GKR
Prescription
10
510(k) clearances
181
Adverse events (1 deaths)
8
Recalls
30
Facilities
Description
The HemoPoint® H2 system is intended for the quantitative determination of hemoglobin (Hgb) in whole blood of adults, infants, and children in a professional point-of-care setting. It consists of a dedicated photometer and individual, single-use microcuvettes filled with reagents.
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 RAPIDLab Blood Gas systems |
| 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 RAPIDLab Blood Gas systems |
| 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 RAPIDLab Blood Gas systems |
| 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 RAPIDLab Blood Gas systems |
| 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 hemoglobin testing sys |
| 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 are all related to the |
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Get your free API keyRead the docsData 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.