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ROTEM® ex-tem®Recalls & reported problems

Tem Innovations GmbH · The EXTEM assay is a semi-quantitative in vitro diagnostic assay used to monitor the coagulation process via the extrinsic pathway in citrated whole blood specimens on the ROTEM® delta. 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). · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04260160470242), received between Jun 21, 2018 and Jun 21, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Output Problem” (1 report).

5 other recalls cover devices cleared under the same FDA submission (K101533); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Output Problem1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 21, 2018Output Problem; Output Problem

    CUSTOMER REPORTED SEEING EXTENDED EX-TEM CT'S ON THEIR ROTEM DELTA INSTRUMENT WITH PATIENT RESULT ON NEW REAGENT LOT. THE CUSTOMER REPORTS THAT TWO PATIENTS WERE POSSIBLY INAPPROPRIATELY TRANSFUSED FRESH FROZEN PLASMA (FFP) DUE TO ERRONEOUS EX-TEM CT VALUES. THE CUSTOMER DID NOT REPORT AN ADVERSE EVENT FROM THE TRANSFUSIONS.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7625899 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K101533. One submission often covers many models, so check the product and lot details in each record.

  • Z-2486-2019 · Jul 23, 2019 · Terminated
    ROTEM ex-tem Canada Part No: 503-05-CA
  • Z-2485-2019 · Jul 23, 2019 · Terminated
    ROTEM ex-tem; US Part No: 503-05-US
  • Z-2487-2019 · Jul 23, 2019 · Terminated
    ROTEM ex-tem Rest of the world part No: 503-05 (ROW)
  • Z-0302-2017 · Sep 13, 2016 · Terminated
    ex-TEM Assay for ROTEM delta Thromboelastometry System. Art. no.: 503-05 US, ex-tem. Used to monitor the coagulation process via the extrinsic pathway in citrated whole blood spe
  • Z-1379-2015 · Oct 23, 2014 · Terminated
    ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH.

Other System, Multipurpose For In Vitro Coagulation Studies devices

All System, Multipurpose For In Vitro Coagulation Studies devices →

Sources and updates

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