FDA recall Z-0100-2024

Product

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.

Distribution

worldwide except US, Canada, and China

Key facts

Status

Ongoing

Initiation date

2023-07-06

Report date

2023-10-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Chaska, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0100-2024