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U.S. Department of Health and Human Services

Class 2 Device Recall Atellica CH Lithium_2 (LITH_2)

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 Class 2 Device Recall Atellica CH Lithium_2 (LITH_2)see related information
Date Initiated by FirmSeptember 19, 2022
Date PostedOctober 20, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0104-2023
Recall Event ID 90900
510(K)NumberK050374 
Product Classification Assay, porphyrin, spectrophotometry, lithium - Product Code NDW
ProductAtellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro diagnostic assay
Code Information UDI-DI: 00630414287935 All lots impacted: Lots 110238 exp 10/18/22 110302 exp 12/13/22 120017 exp 4/18/23
FEI Number 2432235
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information ContactJennifer 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
ActionOn 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 Commerce1342 US; 2266 OUS
DistributionWorldwide distribution - US Nationwide.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = NDW
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