TEG 5000 Functional Fibrinogen Reagent recall
TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034
Why was TEG 5000 Functional Fibrinogen Reagent recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: (01)20812747018095 All lots are affected.
- Product
- TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034
- Recalling firm
- Haemonetics Corporation
- Quantity
- 3933 kits (US); 2429 kits (OUS)
- Distribution
- Domestic distribution US Nationwide.
- Recall date
- July 6, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)