Recall Z-1505-2023— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-1505-2023
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: K962559. Product: ADVIA Centaur Cortisol 50T (Material Number 10994924), ADVIA Centaur Cortisol 250T (Material Number 10994926), and ADVIA Centaur Cortisol REF 250T (Material Number 10994927). 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

K962559 — ACS CORTISOL IMMUNOASSAYCiba Corning Diagnostics Corp.·cleared 1996-11-05

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

ADVIA Centaur Cortisol 50T (Material Number 10994924), ADVIA Centaur Cortisol 250T (Material Number 10994926), and ADVIA Centaur Cortisol REF 250T (Material Number 10994927). 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.