Home › Device types › GFO
Activated Partial Thromboplastin
FDA product code GFO · Class 2 · Hematology
43
Registered devices
97
Adverse events
10
Recalls
52
510(k) clearances
Devices with this code
Dade® Actin® Activated Cephaloplastin Reagent — Siemens Healthcare Diagnostics Products GmbHThermo Scientific Pacific Hemostasis® — Fisher DiagnosticsDade Actin Activated Cephaloplastin Reagent — Siemens Healthcare Diagnostics Products GmbHPathromtin SL — Siemens Healthcare Diagnostics Products GmbHThermo Scientific Pacific Hemostasis® — Fisher DiagnosticsThermo Scientific Pacific Hemostasis® — Fisher DiagnosticsPathromtin® SL — Siemens Healthcare Diagnostics Products GmbHCRYOcheck Hex LA — Precision Biologic IncStaclot® LA — DIAGNOSTICA STAGOSlide Platelet Aggregation Test Reagent — ANALYTICAL CONTROL SYSTEMS INCSTA® - Cephascreen® 4 — DIAGNOSTICA STAGOSTA® - Cephascreen® 10 — DIAGNOSTICA STAGOAPTT-SA (Soluble Activator) Reagent Kit — HELENA LABORATORIES CORPORATIONAPTT-SA (Soluble Activator) Reagent Kit — HELENA LABORATORIES CORPORATIONPathromtin® SL — Siemens Healthcare Diagnostics Products GmbH0.25 M Calcium Chloride — HELENA LABORATORIES CORPORATIONTriniCLOT™ Calcium Chloride 0.025M — TCOAG IRELAND LIMITEDQuikCoag Calcium Choride 0.02M — Biomedica Diagnostics IncThermo Scientific Pacific Hemostasis® — Fisher DiagnosticsAPTT-SA (Soluble Activator) Reagent Kit — HELENA LABORATORIES CORPORATIONCRYOcheck Hex LA — Precision Biologic IncHemosIL SynthASil — INSTRUMENTATION LABORATORY COMPANYTriniCLOT™ Automated aPTT 3 mL — TCOAG IRELAND LIMITEDTriniCLOT™ aPTT S 3 mL — TCOAG IRELAND LIMITED
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-11 | Instrumentation Laboratory | Potential for microbial contamination. |
| 2025-11-18 | Instrumentation Laboratory | Recalled lots were manufactured with double the amount of preservative concentration. |
| 2021-01-05 | Helena Laboratories, Corp. | Intermittent potential for shorter than expected clot times. |
| 2018-11-14 | Diagnostica Stago, Inc. | There have been reports of shortened (T1-T2) results, where some instances of result recovery outside of the range of less than or equal to 15 seconds. |
| 2018-11-14 | Diagnostica Stago, Inc. | There have been reports of shortened (T1-T2) results, where some instances of result recovery outside of the range of less than or equal to 15 seconds. |
| 2017-12-07 | Helena Laboratories, Corp. | Some of the cards show occasional shorter clot times than the expected variation resulting in a potential false negative result on the screening assay. |
| 2015-03-25 | Siemens Healthcare Diagnostics, Inc. | Recovery for assayed controls are out of assigned ranges. A drift >3 seconds in the normal APTT range and/or >15% in the pathological range has been observed. |
| 2013-12-19 | ITC-Nexus Dx | ITC has determined that some Citrate APTT cuvettes may recover higher than expected results in normal individuals. |
| 2006-07-18 | Diagnostica Stago, Inc. | Decrease in sensitivity ; This could result in a false negative result for patients with weak to moderate lupus anticoagulants. |
| 2004-03-01 | Dade Behring , Inc. | cloudy appearance or precipitate |
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