Beckman Coulter, Inc. recalls Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168. The Access…
IFUs for the device incorrectly states the biotin interference was remediated. The issue could result in potentially false-low results.
Read the official notice →- Date
- 2024-11-06
- Country
- United States
- Brand
- Beckman Coulter
- Product
- Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168. The Access…
- Classification
- Class II
- Units
- Distribution was made nationwide to the U.S., including Puerto Rico. There was…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- 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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