Access Thyroglobulin Calibrators
Reported: October 18, 2023 Initiated: July 6, 2023 #Z-0100-2024
Product Description
Access Thyroglobulin Calibrators
Reason for Recall
It has been determined through an internal investigation that the alternate Access Thyroglobulin calibrator cards for use with the Thyg reagent packs distributed in April 2023 will cause a decrease of approximately 11% in patient results.
Details
- Recalling Firm
- Beckman Coulter, Inc.
- Units Affected
- 5980 units
- Distribution
- worldwide except US, Canada, and China
- Location
- Chaska, MN
Frequently Asked Questions
What product was recalled? ▼
Access Thyroglobulin Calibrators. Recalled by Beckman Coulter, Inc.. Units affected: 5980 units.
Why was this product recalled? ▼
It has been determined through an internal investigation that the alternate Access Thyroglobulin calibrator cards for use with the Thyg reagent packs distributed in April 2023 will cause a decrease of approximately 11% in patient results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 18, 2023. Severity: Moderate. Recall number: Z-0100-2024.
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