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.
Reported: May 10, 2023 Initiated: March 16, 2023 #Z-1504-2023
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.
Details
- Recalling Firm
- Siemens Healthcare Diagnostics, Inc.
- Units Affected
- 34,746 kits
- Distribution
- Worldwide distribution - US Nationwide.
- Location
- Tarrytown, NY
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Siemens Healthcare Diagnostics, Inc.. Units affected: 34,746 kits.
Why was this product recalled? ▼
There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 10, 2023. Severity: Moderate. Recall number: Z-1504-2023.
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