Home › Device types › JPA
System, Multipurpose For In Vitro Coagulation Studies
FDA product code JPA · Class 2 · Hematology
169
Registered devices
7,801
Adverse events
43
Recalls
181
510(k) clearances
Devices with this code
TEG5000 — HAEMONETICS CORPORATIONSTA Compact Max® (with cap piercing option) — DIAGNOSTICA STAGOCalcium Chloride Solution — Siemens Healthcare Diagnostics Products GmbHHemosIL Rinse Solution (ACL Futura Advance) — INSTRUMENTATION LABORATORY COMPANYCoagulation Optic (Advance) — INSTRUMENTATION LABORATORY COMPANYOwren's Veronal Buffer — HELENA LABORATORIES CORPORATIONAutomated Blood Coagulation Analyzer CN-3000 — SYSMEX CORPORATIONHemosIL AcuStar — INSTRUMENTATION LABORATORY COMPANYAggRAM Module (Domestic) — HELENA LABORATORIES CORPORATIONAutomated Blood Coagulation Analyzer CS-2500 — SYSMEX CORPORATIONBerichrom® Heparin LMW Calibrator — Siemens Healthcare Diagnostics Products GmbHTEG5000 HEMOSTASIS SYSTEM — HAEMONETICS CORPORATIONROTEM® — Tem Innovations GmbHChromogenic Optic (Advance) — INSTRUMENTATION LABORATORY COMPANYDestiny MAX Analyzer — TCOAG IRELAND LIMITEDAutomated Blood Coagulation Analyzer CS-5100 — SYSMEX CORPORATIONActalyke QC Kit - AQC-LP — HELENA LABORATORIES CORPORATIONROTEM® — Tem Innovations GmbHNORM-TROL 1 Coagulation Control — HELENA LABORATORIES CORPORATIONGlobal Hemostasis - HN — HAEMONETICS CORPORATIONHemochron Whole Blood Microcoagulation System — ACCRIVA DIAGNOSTICS HOLDINGS, INC.HemosIL Special Test Control Level 2 — INSTRUMENTATION LABORATORY COMPANYAggRAM Analyzer, Windows 2000 (110V/220V) — HELENA LABORATORIES CORPORATIONROTEM® — Tem Innovations GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-07-21 | Diagnostica Stago, Inc. | Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications. |
| 2023-03-22 | Diagnostica Stago, Inc. | An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increased freque |
| 2023-03-22 | Diagnostica Stago, Inc. | An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increased freque |
| 2023-03-22 | Diagnostica Stago, Inc. | An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increased freque |
| 2022-04-26 | Haemonetics Corporation | Due to a shift in the citrated blood reference range for a normal population, the ranges stated in the IFU are changing. If the clinician relies solely on affec |
| 2022-04-19 | Haemonetics Corporation | When the TEG 5000 Analyzer including TEG Analytical Software is used with PlateletMapping (ADP or AA) Assays and TEG Mangement Software, incorrect values of the |
| 2021-03-02 | Siemens Healthcare Diagnostics, Inc. | Siemens Healthcare Diagnostics Products GmbH has confirmed that the BCS XP System may be affected by a potential Emicizumab carryover on patient samples. |
| 2020-11-09 | Helena Laboratories, Corp. | Due to complaints received associated with cracked/split test tube caps. |
| 2020-02-19 | Haemonetics Corporation | Software defect in TEG Manager impacts the displayed alert for out of range test results. Due to this defect, reference range values received from TEG 5000 and |
| 2019-07-23 | Instrumentation Laboratory Co. | Prolonged clotting times |
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