Z-1505-2023 Class II Ongoing
FDA device recall Z-1505-2023 was initiated by Siemens Healthcare Diagnostics, Inc. on March 16, 2023 and is designated Class II. Reason for recall: There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low. The recall status is ongoing. Affected quantity: 18,961 kits.
Recall Details
- Product Type
- Devices
- Report Date
- May 10, 2023
- Initiation Date
- March 16, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18,961 kits
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.
Distribution Pattern
Worldwide distribution - US Nationwide.
Code Information
ADVIA Centaur Cortisol (50T) UDI-DI: 00630414602943; Kit Lot Numbers: 49741344 07241346 88318346 29109348 and higher; ADVIA Centaur Cortisol 250T UDI-DI: 00630414602950; Kit Lot Numbers: 49742344 88319346 29108348 and higher; ADVIA Centaur Cortisol (REF) 250T UDI-DI: 00630414598659; Kit Lot Numbers: 75474344 11352346 and higher