Home › Device types › DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
FDA product code DAP · Class 2 · Hematology
49
Registered devices
226
Adverse events
13
Recalls
58
510(k) clearances
Devices with this code
NA — REMEL EUROPE LIMITEDTriniCHECK™ D-Dimer 2 — TCOAG IRELAND LIMITEDACTISCREEN XL-FDP — Biomedica ADI Inc.D-Dimer Control I/II — Roche Diagnostics GmbHINNOVANCE® D-Dimer Controls — Siemens Healthcare Diagnostics Products GmbHHemosIL D-Dimer HS 500 — INSTRUMENTATION LABORATORY COMPANYDIMERTEST Latex assay — Biomedica ADI Inc.FDP Plasma — DIAGNOSTICA STAGOStratus® CS Acute Care™ DDMR TestPak — Siemens Healthcare Diagnostics Inc.Dade® DIMERTEST® Latex Beads — Siemens Healthcare Diagnostics Products GmbHD-Dimer AccuBind ELISA Test System - 96 Wells — MONOBIND, INC.HemosIL D-Dimer HS 500 — INSTRUMENTATION LABORATORY COMPANYINNOVANCE® D-Dimer — Siemens Healthcare Diagnostics Products GmbHD-Dimer AccuBind ELISA Test System - 192 Wells — MONOBIND, INC.FDP Plasma (Latex) — DIAGNOSTICA STAGOINNOVANCE® D-Dimer Sample Diluent — Siemens Healthcare Diagnostics Products GmbHNA — REMEL EUROPE LIMITEDTriniLIA™ D-Dimer — TCOAG IRELAND LIMITEDSTA® - Liatest® D-Di — DIAGNOSTICA STAGOD-Dimer AccuLite CLIA Test System - 192 Wells — MONOBIND, INC.HemosIL AcuStar D-Dimer — INSTRUMENTATION LABORATORY COMPANYINNOVANCE D-Dimer Controls — Siemens Healthcare Diagnostics Products GmbHThrombo-Wellcotest Glycine Saline — REMEL EUROPE LIMITEDDiazyme — DIAZYME LABORATORIES, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-02-05 | Diagnostica Stago, Inc. | After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range. |
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-09-12 | Diagnostica Stago, Inc. | A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots. |
| 2021-09-22 | bioMerieux, Inc. | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to pote |
| 2015-11-11 | Siemens Healthcare Diagnostics Inc | Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems |
| 2013-04-17 | BioMerieux SA | Customer complaints about not repeatable results below the detection limit (<45 ng/mL). Therefore false negatives are being reported for results around the med |
| 2012-06-07 | Siemens Healthcare Diagnostics, Inc. | Siemens has confirmed that the Stratus(R) CS Acute Care(TM) D-Dimer CalPak calibrator lots 502058002 and 501318002 may exhibit SLOPE or CALCV error messages (in |
| 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 |
| 2006-04-03 | Dade Behring , Inc. | Foil sealing of the TestPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associ |
| 2006-04-03 | Dade Behring , Inc. | Foil sealing of the DilPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associa |
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