Haemonetics Corporation TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034
Brand
Haemonetics Corporation
Lot Codes / Batch Numbers
UDI-DI: (01)20812747018095 All lots are affected.
Products Sold
UDI-DI: (01)20812747018095 All lots are affected.
Haemonetics Corporation is recalling TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034 due to Due to a shift in the citrated blood reference range for a normal population, the ranges stated in the IFU are changing. If the clinician relies solel. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to a shift in the citrated blood reference range for a normal population, the ranges stated in the IFU are changing. If the clinician relies solely on affected results in comparison to the normal donor reference range, it could lead to misdiagnosis and incorrect treatment or failure to treat.
Recommended Action
Per FDA guidance
On April 26, 2022, affected customers were provided with a recall letter via email. Customers may continue to use the TEG 5000 Functional Fibrinogen reagent with the current IFU in conjunction with the letter which reflects the updated ranges. Haemonetics will provide a revision to the IFU. Additionally, customers using Functional Fibrinogen reagent are being reminded to continue to follow the instructions in the current Instructions for Use (118474-MULTI (XX)), which state - Results from the TEG analyzer should not be the sole basis for a patient diagnosis TEG analyzer results should be considered along with a clinical assessment of the patient's condition and other coagulation laboratory tests.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026