Access Thyroglobulin Calibrators recallZ-0100-2024 · Beckman Coulter, Inc. · initiated Jul 6, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Beckman Coulter, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Other
What the company is doing
Beckman Coulter issued an Urgent Medical Device Recall letter dated 06/28/2023 to its consignees affected worldwide on 07/06/2023 via email or letter and followed with an updated letter (dated 07/07/2023) issued on 07/14/2023 which contained FDA suggested edits. The notice explained the problem, the risk to the patient and requested the following actions be taken: If you have downloaded the alternative calibrator card issued in April 2023, please discard that calibrator card, and do not use it moving forward. . Only use Access Thyroglobulin calibrator lots 338013 or higher to calibrate Access Thyg reagent packs (C71762), when this becomes available in your laboratory. . Continue to use any lot of Thyroglobulin Calibrator (PN 33865) with Access Thyroglobulin Reagent packs (33860). The firm issued an Important Product Notification letter was issued on 2023 August 10 notifying customers in the US, Canada, and China that they were NOT affect by this issue and to disregard the prior Urgent Medical Device Recall letters.
Recall details
- Recall number
- Z-0100-2024
- Status
- Open, Classified
- Initiated by the company
- Jul 6, 2023
- Posted by the FDA
- Oct 11, 2023
- Recalling firm
- Beckman Coulter, Inc.
- Quantity
- 5980 units
- Product code
- MSW
- FDA submissions
- K031269
- Distribution
- worldwide except US, Canada, and China
Product description
Access Thyroglobulin Calibrators
Code information (models, lots, serial numbers)
UDI/DI 15099590227166, Serial/Lot Numbers: 233806, 234171, 234355, 234443, 234444, 234617, 337940
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Access Thyroglobulin Calibrators 33865Beckman Coulter, Inc. · System,Test,Thyroglobulin1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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