Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and REF 250T (Material Number 1120
Summary
The FDA issued a Class II for Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995 by Siemens Healthcare Diagnostics, Inc.. Reason: There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low..
Details
Source
Device Recall
External ID
Z-1504-2023
Action Date
2023-05-10
Status
Ongoing
Category
device
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.
Lot/Code Info: 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
Quantity Affected: 34,746 kits
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
Worldwide distribution - US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-03-16
Company
Tarrytown, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 168 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Siemens Healthcare Diagnostics, Inc. has 166 FDA actions in our database, including 142 recalls and 24 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Siemens Healthcare Diagnostics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Siemens Healthcare Diagnostics, Inc. have FDA actions?
Siemens Healthcare Diagnostics, Inc. has 166 FDA actions in our database, including 142 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1504-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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