Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay
Summary
The FDA issued a Class II for Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic by Siemens Healthcare Diagnostics, Inc.. Reason: 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.
Details
Source
Device Recall
External ID
Z-0105-2023
Action Date
2022-10-26
Status
Ongoing
Category
device
Product Description
Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay
Lot/Code Info: UDI-DI: 00630414006789 All lots impacted: Lots 110354 exp 11/15/22 120038 exp 2/7/23
Quantity Affected: 586 US; 694 OUS
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.
Distribution
Worldwide distribution - US Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-09-19
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 184 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-0105-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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