Recall Z-1504-2023— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-1504-2023
Creator: U.S. Food and Drug Administration
Published: 2023-03-16

Class II · Ongoing

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2023-03-16. It names one FDA 510(k) clearance: K142723. 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: There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-03-16
Firm location: Tarrytown, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K142723 — ADVIA Centaur Cortisol (COR) AssySiemens Healthcare Diagnostics, Inc.·cleared 2015-03-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.