TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034
FDA Recall Z-1310-2022 · Posted None
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Recalling FirmHaemonetics Corporation
Recall StatusTerminated
Product CodeJPA
Date Initiated2022-04-26
Date Terminated2024-03-15
Product Quantity3933 kits (US); 2429 kits (OUS)
Reason for Recall
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.
Firm Action
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.
Root Cause
Other
Distribution Pattern
Domestic distribution US Nationwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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