FDA Recalls TEG 5000 Fibrinogen Reagent Kits Due to Outdated Reference Ranges
Haemonetics Corporation is recalling TEG 5000 Functional Fibrinogen Reagent kits because the reference ranges in the instructions have shifted. Clinicians using these outdated ranges could misdiagnose patients or fail to provide necessary treatment.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall of a diagnostic device with incorrect reference ranges that could lead to misdiagnosis or failure to treat. No illnesses or injuries have been reported, and the hazard is theoretical. Per the rubric, risk-of-harm products without reported injury score as High (3).
Plain-English summary
Haemonetics Corporation is recalling TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034, distributed to medical facilities nationwide. The recall affects 3,933 kits in the US and 2,429 kits distributed overseas. All lots of the product are included.
The normal population citrated blood reference ranges stated in the product's instructions for use (IFU) have shifted. The reference ranges in the current IFU no longer reflect the correct normal population values.
If clinicians rely solely on results compared to the outdated normal donor reference ranges in the IFU, they could reach incorrect diagnoses or fail to treat patients requiring treatment. This creates a risk of misdiagnosis and potentially inappropriate clinical decisions.
Haemonetics Corporation is working with the FDA on this Class II recall. Users should review updated instructions and reference ranges, and may need to retest recent patient samples using the corrected reference ranges if clinically appropriate. Contact Haemonetics Corporation for updated information.
The recalled product
- Product
- TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034
- Manufacturer
- Haemonetics Corporation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: (01)20812747018095 All lots are affected.
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Haemonetics Corporation
See all →- HighTEG5000 Analyzer displays incorrect PlateletMapping assay results in TEG Manager
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 Japan Disp Sets Due to Potential Bowl Cracks
FDA (Devices) · 2020-02-05
- HighHaemonetics Recalls Cell Saver 5/5+ Bowl Kits Due to Leak Risk
FDA (Devices) · 2020-02-05
Same hazard · incorrect reference range
See all →- HighREMISOL Advance Medical Device Software Defect Affecting Reference Range Calculations
FDA (Devices) · 2025-07-02