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ROTEM®

Tem Innovations GmbH · Model delta System (US/CA) · UDI-DI 04260160470587

GGN JPA

510(k) clearances

148

Adverse events

Recalls

Facilities

Description

The ROTEM® delta is designed for in-vitro diagnostic use by professionals in a laboratory environment. The ROTEM® delta is intended to be used to provide a qualitative and quantitative indication of the coagulation state of a blood sample. For this purpose the ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. The analyzer output consists of a qualitative graphical representation (mirrored coagulation curve - clot firmness over time) and several defined numerical parameters describing the curve quantitatively.

Recalls

Date	Firm	Reason
2026-07-01	Aniara Diagnostica LLC	Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a degradation of measurable bivalirudin
2026-04-30	Accriva Diagnostics, Inc.	Assayed Whole blood control contains labeling with incorrect performance range.
2022-06-28	Aniara Diagnostica LLC	Incorrect product labeling was included in the package.
2019-11-18	Diagnostica Stago, Inc.	A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX and STA - Deficient VIII when compared to the International Standard (IS) for fact
2019-03-19	Aniara Diagnostica LLC	The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
2019-03-19	Aniara Diagnostica LLC	The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
2019-03-19	Aniara Diagnostica LLC	The manufacturer packaged incorrect versions of the Instructions for Use into specific lots for three device product codes.
2016-02-18	TEM Systems Inc	Customer complaints about failed target ranges for alpha angle. Firm has not completed the CAPA identifying the root cause. Projected completion of the CAPA by the firm is July 201
2013-11-15	Instrumentation Laboratory Co.	HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval
2013-11-15	Instrumentation Laboratory Co.	HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval

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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.