TEG6s HEMOSTASIS SYSTEM 07-690-USRecalls & reported problems

Haemonetics Corporation · TEG 6S UNIT PACK · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30812747018351), received between Feb 20, 2020 and Feb 20, 2020 — classified as 1 death.

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

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 18, 2026.

Most reported problems

Device problems

Insufficient Device Problem Information1

Patient problems

Death1

Recent adverse event reports

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

DeathFeb 20, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
ON (B)(6) 2020, CUSTOMER INFORMED HAEMONETICS OF A PATIENT FATALITY THAT HAPPENED AT (B)(6) MEDICAL CENTER IN (B)(6). PALETTE MAPPING, ON A TEG6S, GAVE A SUDLITE ERROR IN THE MIDDLE OF TESTING AND THERE WAS A DELAY IN OBTAINING THE RESULTS.
Patient problems: Death
MAUDE report 9733033 ↗

Device details

UDI-DI	`30812747018351`
Brand	TEG6s HEMOSTASIS SYSTEM
Model	07-690-US
Company	Haemonetics Corporation
Product code	JOZ · SYSTEM, AUTOMATED PLATELET AGGREGATION
Class	Class 2
FDA submission	K140893
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 16, 2022

Device type (GMDN): Coagulation analyser IVD, laboratory

An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of one or multiple coagulation components involved in haemostasis in a clinical specimen [e.g., performs tests such as prothrombin time (PT), partial thromboplastin time (PTT)]. Analyser design may incorporate spectrophotometry, turbidimetry, nephelometry, electrometry, electromagnetic and/or mechanical means of clot formation or end point detection.

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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