System, Multipurpose For In Vitro Coagulation Studies
FDA adverse event reports and recall history for system, multipurpose for in vitro coagulation studies (product code JPA), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 7,798
- Deaths
- 39
- Injuries
- 494
- Malfunctions
- 7,165
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2025-08-28Open, ClassifiedMixed-up of materials/components
STA Satellite. Product Code: All references. All software versions. The STA Satellite is a fully automated benchtop analyzer capable of simultaneously performing clotting, chromogenic, and immunologic assays.
Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
- 2023-05-10Open, ClassifiedDevice Design
STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026
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 a technical error reported by the analyzer (error 13).
- 2023-05-10Open, ClassifiedDevice Design
STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612
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 a technical error reported by the analyzer (error 13).
- 2023-05-10Open, ClassifiedDevice Design
STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612
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 a technical error reported by the analyzer (error 13).
- 2016-02-19TerminatedSoftware design
BCS Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10454728 (BCS RECONDITIONED), 10454729 (BCS RECONDITIONED), 10454742 (BEHRING COAGULATION SYSTEM), 10459303 (BCS RECONDITIONED), 10460659 (BCS INSTRUMENT), 10461881 (BCS INSTRUMENT), IVD --- Device Listing D018966
False short clotting times for PT on BCS and BCS XP with Dade Innovin can occur. This has also an effect for false low PT INR values. These false short clotting times were observed only with turbid, hemolytic and/or icteric samples from intensive care patients. The corresponding reaction curves of these samples showed a pre-peak, which can lead to falsely short clotting time. The result was not flagged by the existing check algorithms.
- 2016-02-19TerminatedSoftware design
BCS XP Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10459330 (BCS XP SYSTEM, COMPLETE), 10462449 (BCS XP ANALYZER SYSTEM), 10461894 (BCS XP), 10470625 (BCS XP REFURBISHED); IVD --- Device Listing D060801
False short clotting times for PT on BCS and BCS XP with Dade Innovin can occur. This has also an effect for false low PT INR values. These false short clotting times were observed only with turbid, hemolytic and/or icteric samples from intensive care patients. The corresponding reaction curves of these samples showed a pre-peak, which can lead to falsely short clotting time. The result was not flagged by the existing check algorithms.
- 2015-04-03TerminatedNonconforming Material/Component
ROTROL P Control for ROTEM delta Thromboelastometry System, Manufactured for: Tem Innovations GmbH.
Some of vials were found to be partially filled.
- 2015-02-19TerminatedProcess control
Haemonetics TEG Hemostasis System Level II Control, Catalog number: 8002. Level II Control is a biological control for use with the Thrombelastograph (TEG) Hemostasis System.
Specific lots of Level II Control Kits produce high Maximum Amplitude (MA) results, which are outside of the manufacturer's expected Quality Control range for MA parameter.
- 2014-07-21TerminatedDevice Design
Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103.
Test results may be erroneously elevated or report an out-of-range high (OOR-H) error code in non heparinized blood samples.
- 2013-07-24TerminatedLabeling False and Misleading
TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation Studies
Research Use Only (RUO) parameters were included in TEG 5000 User Manual.
Monitor system, multipurpose for in vitro coagulation studies automatically
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