TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034
Reported: July 6, 2022 Initiated: April 26, 2022 #Z-1310-2022
Product Description
TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034
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.
Details
- Recalling Firm
- Haemonetics Corporation
- Units Affected
- 3933 kits (US); 2429 kits (OUS)
- Distribution
- Domestic distribution US Nationwide.
- Location
- Boston, MA
Frequently Asked Questions
What product was recalled? ▼
TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034. Recalled by Haemonetics Corporation. Units affected: 3933 kits (US); 2429 kits (OUS).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 6, 2022. Severity: Moderate. Recall number: Z-1310-2022.
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