Drugs & medicalClass II

Haemonetics Corporation recalls TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034

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…

Read the official notice →
Date
2022-07-06
Country
United States
Brand
Haemonetics
Product
TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034
Classification
Class II
Units
Domestic distribution US Nationwide.
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

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