Z-1504-2023 Class II Ongoing
FDA device recall Z-1504-2023 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: 34,746 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
- 34,746 kits
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.
Distribution Pattern
Worldwide distribution - US Nationwide.
Code Information
Atellica IM Cortisol (50T) UDI-DI: 00630414598659; Kit Lot Numbers: 50732343 50733343 88975345 29106347 29107347 and higher; Atellica IM Cortisol 250T UDI-DI: 00630414598642; Kit Lot Numbers: 50734343 88974345 29105347 and higher; Atellica IM Cortisol (REF) 250T UDI-DI: 00630414293608; Kit Lot Numbers: 53842343 58039343 94430345 and higher