Access Thyroglobulin Calibrators recall
Access Thyroglobulin Calibrators
Why was Access Thyroglobulin Calibrators 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 15099590227166, Serial/Lot Numbers: 233806, 234171, 234355, 234443, 234444, 234617, 337940
- Product
- Access Thyroglobulin Calibrators
- Recalling firm
- Beckman Coulter, Inc.
- Quantity
- 5980 units
- Distribution
- worldwide except US, Canada, and China
- Recall date
- October 18, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)