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.
Reported: November 6, 2024 Initiated: September 5, 2024 #Z-0265-2025
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.
Reason for Recall
IFUs for the device incorrectly states the biotin interference was remediated. The issue could result in potentially false-low results.
Details
- Recalling Firm
- Beckman Coulter, Inc.
- Units Affected
- 465,481 kits
- 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.
- Location
- Chaska, MN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Beckman Coulter, Inc.. Units affected: 465,481 kits.
Why was this product recalled? ▼
IFUs for the device incorrectly states the biotin interference was remediated. The issue could result in potentially false-low results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 6, 2024. Severity: Moderate. Recall number: Z-0265-2025.
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