FDA recall Z-1504-2023

Product

Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and REF 250T (Material Number 11206248). In vitro diagnostic use in the quantitative determination of cortisol in human serum, plasma (EDTA and lithium heparin), and urine.

Reason for recall

There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low.

Distribution

Worldwide distribution - US Nationwide.

Key facts

Status

Ongoing

Initiation date

2023-03-16

Report date

2023-05-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tarrytown, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1504-2023