Haemonetics TEG Hemostasis System Level II Control Recall
Haemonetics is recalling specific lots of TEG Hemostasis System Level II Control kits because they produce high Maximum Amplitude results outside the expected quality control range.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Haemonetics Corporation is recalling 4,143 kits of the TEG Hemostasis System Level II Control, catalog number 8002. This product is a biological control used with the Thrombelastograph (TEG) Hemostasis System.
The recall is being issued because specific lots of these control kits produce high Maximum Amplitude (MA) results. These results fall outside of the manufacturer's expected Quality Control range for the MA parameter.
The affected lots are HMO 9200, HMO 9217, HMO 9226, HMO 9232, HMO 9276, HMO 9285, and HMO 9292, all with an expiration date of 1/2017. The products were distributed worldwide, including in the US, Canada, Czech Republic, Denmark, Great Britain, and Sweden. Users should stop using the affected lots and contact Haemonetics Corporation for further instructions.
The recalled product
- Product
- 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.
- Manufacturer
- Haemonetics Corporation
- Hazard
- Affected units
- 4,143
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Haemonetics Corporation
See all →- HighTEG5000 Analyzer displays incorrect PlateletMapping assay results in TEG Manager
FDA (Devices) · 2022-07-06
- HighFDA Recalls TEG 5000 Fibrinogen Reagent Kits Due to Outdated Reference Ranges
FDA (Devices) · 2022-07-06
- ModerateHaemonetics Recalls TEG Manager Software Due to Alert Display Defect
FDA (Devices) · 2020-04-08
- HighHaemonetics Recalls CS Elite Processing Sets Due to Potential Bowl Cracks
FDA (Devices) · 2020-02-05
- HighHaemonetics Recalls CS5/5+ Bowl Kits Due to Potential Leaks
FDA (Devices) · 2020-02-05
Same hazard · quality control failure
See all →- High5-PLASMA Bivalirudin AMR Verification Kit Recalled Due to Stability Issues
FDA (Devices) · 2026-08-12
- HighEXENT Analyser marked plates as passed without performing quality control
FDA (Devices) · 2026-06-17
- HighPreeclampsia growth factor assay recalled over out-of-range quality control values
FDA (Devices) · 2026-04-15
- HighSusceptibility test cards recalled over false resistant antibiotic results
FDA (Devices) · 2026-02-11
- ModerateHeparin control material recalled after quality control results fell below acceptance range
FDA (Devices) · 2025-08-20