Date Initiated by Firm |
March 16, 2023 |
Date Posted |
May 03, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1504-2023 |
Recall Event ID |
92059 |
510(K)Number |
K142723
|
Product Classification |
Fluorometric, cortisol - Product Code JFT
|
Product |
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. |
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 |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics, Inc. 511 Benedict Ave Tarrytown NY 10591-5005
|
For Additional Information Contact |
Customer Care Center 312-275-7795
|
Manufacturer Reason for Recall |
There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low.
|
FDA Determined Cause 2 |
Under Investigation by firm |
Action |
An Urgent Medical Device Correction notification letter dated 3/17/23 was sent to customers.
Actions to be Taken by the Customer
Discontinue use of urine patient samples with the Atellica IM Cortisol and ADVIA Centaur Cortisol assays until further notice.
Customers may continue to use serum and plasma sample types with the Atellica IM Cortisol and ADVIA Centaur Cortisol assays.
Please review this letter with your Medical Director to determine the appropriate course of action, including for any previously generated results, if applicable.
Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days.
If you have received any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.
Please retain this letter with your laboratory records and forward this letter to those who may have received this product.
We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.
An additional Resolution Customer Notification letter dated 2/29/24 was sent to customers explaining an improvement to raw material specification that restores assay performance with urine samples. Customers are asked to follow the instructions for urine patient samples and urine cortisol QC as stated in the notification and if using products listed in the original field action notice continue following the guidance as stated in the Field Action Letter. Customers with any questions are to contact the Customer Care Center or local Siemens Healthineers technical support representative. |
Quantity in Commerce |
34,746 kits |
Distribution |
Worldwide distribution - US Nationwide. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database |
510(K)s with Product Code = JFT and Original Applicant = Siemens Healthcare Diagnostics Inc.
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