The Recall Desk

Manufacturer

TEM Systems Inc

3 recalls in our database name TEM Systems Inc as the manufacturing or recalling firm.

What the numbers show

Total
3
Critical
0
Severe
0
Most recent
2016-11-02

Of the 3 recalls from TEM Systems Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–3 of 3

  • ModerateFDA (Devices)·Z-0302-2017·2016-11-02

    TEM Systems Recalls ex-TEM Assay Reagents Due to Low Vial Levels

    TEM Systems Inc is recalling ex-TEM Assay reagents for the ROTEM delta system because customers reported low or empty vials.

    Product
    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 specimens on the ROTEM delta.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1090-2016·2016-03-16

    TEM Systems Recalls ROTROL P Control for Thromboelastometry System

    TEM Systems Inc is recalling ROTROL P Control quality control material due to customer complaints about failed target ranges for alpha angle.

    Product
    ROTROL P Control for ROTEM delta Thromboelastometry System, For In Vitro Diagnostic Use Only. Quality control material for monitoring accuracy and precision of test carried out on the ROTEM delta Thromboelastometry System.
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-1379-2015·2015-04-15

    TEM Systems Recalls ROTROL P Control Vials Due to Partial Filling

    TEM Systems Inc is recalling specific lots of ROTROL P Control vials because some were found to be partially filled.

    Product
    ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH.
    Category
    Medical Device
    Distribution
    Distributed nationwide