Siemens Healthcare Diagnostics, Inc. recalls Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and REF 250T (Material Number 1120

Recalled May 10, 2023 · FDA recall Z-1504-2023 · Siemens Healthcare Diagnostics

Hazard

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

Units

34,746 kits

Sold at

Worldwide distribution - US Nationwide.

Description

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

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.

Manufacturer(s)

Siemens Healthcare Diagnostics, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →