FDA Recalls TEG 5000 Fibrinogen Reagent Kits Due to Outdated Reference Ranges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 Clinicians using these outdated ranges could misdiagnose patients or fail to provide necessary treatment.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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If clinicians rely solely on results compared to the outdated normal donor reference ranges in the IFU, they could reach incorrect diagnoses or fail to treat patients requiring treatment.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.
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