Recall Atlas
Drugs & medicalClass II

Future Diagnostics Solutions B.V. recalls Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.

Due to an issue of high coefficient of variability (CV) problem caused by the accuspheres inside the Immunoassay kits.

Read the official notice →
Date
2023-02-01
Country
United States
Brand
Future Diagnostics Solutions B.V.
Product
Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.
Classification
Class II
Units
Worldwide distribution. US states of AZ, CA, CO, LA, OH, PA, and TX; Austria,…
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 Details may be shortened or out of date; the official notice is the authoritative source.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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