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U.S. Department of Health and Human Services

Class 2 Device Recall Atellica CH Lithium (Li)

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  Class 2 Device Recall Atellica CH Lithium (Li) see related information
Date Initiated by Firm September 19, 2022
Date Posted October 20, 2022
Recall Status1 Open3, Classified
Recall Number Z-0105-2023
Recall Event ID 90900
510(K)Number K050374  
Product Classification Assay, porphyrin, spectrophotometry, lithium - Product Code NDW
Product Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay
Code Information UDI-DI: 00630414006789 All lots impacted: Lots 110354 exp 11/15/22 120038 exp 2/7/23
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information Contact Jennifer Beecher
914-631-8000
Manufacturer Reason
for Recall		 Potential for falsely elevated LITH_2 and Li results on the Atellica CH 930 Analyzer. In the worst case, there is a potential for erroneously elevated lithium patient results, which may lead to inappropriate dosage adjustment, potentially affecting treatment efficacy.
FDA Determined
Cause 2		 Under Investigation by firm
Action On September 19, 2022, the firm issued an Urgent Medical Device Correction letter to affected customers. Customers should take the following actions: -Please review this letter with your Medical Director. -Discontinue use of and discard the affected product. Siemens is temporarily discontinuing production and distribution of the Atellica CH lithium reagents until the issue is resolved. In the interim, Siemens is recommending that customers transition to an alternate lithium assay.
Quantity in Commerce 586 US; 694 OUS
Distribution Worldwide 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 = NDW and Original Applicant = BAYER HEALTHCARE, LLC
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