Home › Device types › GHH
Fibrin Split Products
FDA product code GHH · Class 2 · Hematology
19
Registered devices
188
Adverse events
9
Recalls
28
510(k) clearances
Devices with this code
K-ASSAY® D-Dimer Reagent — KAMIYA BIOMEDICAL COMPANY, LLCK-ASSAY® D-Dimer Calibrator — KAMIYA BIOMEDICAL COMPANY, LLCTina-quant D-Dimer — Roche Diagnostics GmbHAU — Beckman Coulter, Inc.Thermo Scientific Pacific Hemostasis® — Fisher DiagnosticsDiazyme — DIAZYME LABORATORIES, INC.Diazyme — DIAZYME LABORATORIES, INC.TriniLIA™ D-Dimer Saline — TCOAG IRELAND LIMITEDTina-quant D-Dimer — Roche Diagnostics GmbHTina-quant D-Dimer — Roche Diagnostics GmbHThermo Scientific Pacific Hemostasis® — Fisher DiagnosticsD-Di Test® — DIAGNOSTICA STAGOAU — Beckman Coulter, Inc.Thermo Scientific Pacific Hemostasis® — Fisher DiagnosticsThermo Scientific Pacific Hemostasis® — Fisher DiagnosticsPATHFAST D-Dimer — PHC CORPORATIONDiazyme — DIAZYME LABORATORIES, INC.Thermo Scientific Pacific Hemostasis® — Fisher DiagnosticsAU — Beckman Coulter, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-10-03 | Roche Diagnostics Operations, Inc. | Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples. |
| 2016-08-16 | Lsi Medience Corporation | Two complaints were received about decrease in sensitivity (control value and/or calibration value) of the product. |
| 2016-06-01 | BBI SOLUTIONS OEM LTD | A component of the kit is showing a sensitivity performance detected in stability testing at 15 months of an 18-month shelf life. Qualitative results may be af |
| 2014-05-02 | Alere San Diego, Inc. | Alere initiated this recall because a limited number of Alere Triage D-Dimer devices from PN 98100 Lot W53884B were incorrectly manufactured. As a result, when |
| 2012-05-22 | Alere San Diego, Inc. | Certain lots of the affected products may have significantly decreased precision relative to the package insert, which could result in an increased frequency of |
| 2011-06-13 | Tcoag Us, Incorporated | There is a performance issue with Minutex D-Dimer Kit which may cause false negative results for patient samples containing levels of greater than 250ng/mL D-Di |
| 2007-02-15 | Inverness Medical Professional Diagnostics | Lot PX018A is exhibiting a decrease in sensitivity affecting the qualitative result around the cut off. |
| 2005-06-21 | Dade Behring , Inc. | positive control shows weak agglutination reaction |
| 2004-07-01 | Fisher Diagnostic, A Company of Fisher Scientific LLC | Defective reagent may cause in vitro diagnostic test kit to yield false positive test results in clinical samples. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.