Home › Device types › GJA
Test, Thrombin Time
FDA product code GJA · Class 2 · Hematology
8
Registered devices
15
Adverse events
4
Recalls
20
510(k) clearances
Devices with this code
Test Thrombin Reagent — Siemens Healthcare Diagnostics Products GmbHTest Thrombin Reagent — Siemens Healthcare Diagnostics Products GmbHHemosIL Thrombin Time — INSTRUMENTATION LABORATORY COMPANYSTA® - Thrombin 10 — DIAGNOSTICA STAGOThrombin Clotting Time Reagent — HELENA LABORATORIES CORPORATIONSTA® - Thrombin 2 — DIAGNOSTICA STAGOT-tek — R 2 DIAGNOSTICS, INC.BC Thrombin Reagent — Siemens Healthcare Diagnostics Products GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2017-10-17 | Siemens Healthcare Diagnostics | The BC Thrombin Reagent kit lot 46751 (contains Thrombin Reagent lot 517468) and kit lot 47184 (contains Thrombin Reagent lot 517469) produce unexpected prolong |
| 2004-08-20 | bioMerieux | Complaints were received from the field regarding prolonged clot times, high control values and erratic results. |
| 2004-08-20 | bioMerieux | Complaints were received from the field regarding prolonged clot times, high control values and erratic results. |
| 2004-07-21 | Dade Behring , Inc. | The product does not demonstrate the expected prolonged thrombin times for specimens obtained from patients recieving heparin |
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.