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ROTEM®

Tem Innovations GmbH · Model ap-tem® · UDI-DI 04260160470068

JPA

510(k) clearances

7,801

Adverse events (39 deaths)

Recalls

Facilities

Description

The APTEM assay is a semi-quantitative in vitro diagnostic assay on the ROTEM® delta Thromboelastometry System to monitor the clot firmness of citrated whole blood specimens after blocking hyperfibrinolysis by aprotinin. ap-tem® is always used in conjunction with ex-tem®. Clotting characteristics are described by the functional parameters Clotting Time (CT), Speed of Clot Formation (CFT and alpha angle), Clot Firmness (A20/MCF) and Clot Lysis (LOT, ML, LI(x)). CFT and alpha (Speed of Clot Formation) are complementary parameters and should be used in conjunction with the main parameters Clotting Time (CT) and Clot Firmness (A20/MCF).

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 frequency of occurrence of
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 frequency of occurrence of
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 frequency of occurrence of
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 affected results in compa
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 PlateletMapping ADP
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 displayed on the TEG
2019-07-23	Instrumentation Laboratory Co.	Prolonged clotting times

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.