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U.S. Department of Health and Human Services

Class 2 Device Recall Atellica CH Calcium_2

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  Class 2 Device Recall Atellica CH Calcium_2 see related information
Date Initiated by Firm February 09, 2022
Create Date April 14, 2022
Recall Status1 Open3, Classified
Recall Number Z-0928-2022
Recall Event ID 89740
510(K)Number K083386  
Product Classification Azo dye, calcium - Product Code CJY
Product Atellica CH Calcium_2 (CA_2), Siemens Material Number 11097644
Code Information UDI: 00630414220697; Lot Numbers: 211392 211438 211484 211522 211526
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information Contact
914-631-8000
Manufacturer Reason
for Recall		 Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results.
FDA Determined
Cause 2		 Device Design
Action Urgent Medical Device Correction notification letters dated 2/9/22 were sent to customers. Actions to be Taken by the Customer Please review this letter with your Medical Director. Perform the instructions provided in the Additional Information section below. 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 these products. Additional Information If your laboratory has multiple Atellica CH 930 Analyzers, separate the assays as follows: -LITH_2 from CA_2 and TBil_2 -A1c_E/A1c_H from CA_2 - CA_2 from UN_c (urine only); UN_c serum and plasma are not impacted and can be run on the same analyzer as CA_2 -Fruc from AAT, IgA_2, IgM_2 and Theo If you choose not to separate the assays as indicated above, batch testing of A1c_E, Fruc, LITH_2, and UN_c (urine only) may be considered. Note: An RPC2 wash mitigation must be initiated after completion of A1c_E, Fruc, LITH_2, and prior to UN_c (urine only). Any of the following will initiate the RPC2 wash: -After the Atellica CH 930 Analyzer has been in standby for 12 minutes. - After completion of any Open Channel assay. - Restarting the Atellica CH 930 Analyzer. Refer to the Atellica Solution Online Help for instructions on system restart. If you have any questions, contact your local Siemens Healthineers technical support representative.
Quantity in Commerce 2,395
Distribution Global Distribution. US Nationwide.
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = CJY and Original Applicant = SIEMENS HEALTHCARE DIAGNOSTICS
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