Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168. The
Summary
The FDA issued a Class II for Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, I by Beckman Coulter, Inc.. Reason: IFUs for the device incorrectly states the biotin interference was remediated. The issue could result in potentially false-low results..
Details
Source
Device Recall
External ID
Z-0265-2025
Action Date
2024-11-06
Status
Ongoing
Category
device
Product Description
Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168. The Access Thyroglobulin Antibody II (TgAb) assay is used for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems.
Lot/Code Info: All IFU Part Numbers B14994, B63978, and A38168 affect all product/lots shipped from Jul-2021 to current; UDI-DI 15099590202910.
Quantity Affected: 465,481 kits
Reason for Recall
IFUs for the device incorrectly states the biotin interference was remediated. The issue could result in potentially false-low results.
Distribution
Distribution was made nationwide to the U.S., including Puerto Rico. There was government distribution but no military distribution. Foreign distribution was made to Mexico.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-09-05
Company
Chaska, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 243 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Beckman Coulter, Inc. has 158 FDA actions in our database, including 111 recalls and 47 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Beckman Coulter, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Beckman Coulter, Inc. have FDA actions?
Beckman Coulter, Inc. has 158 FDA actions in our database, including 111 recalls and 47 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0265-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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