Atellica CH Lithium recall
Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay
Why was Atellica CH Lithium recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 00630414006789 All lots impacted: Lots 110354 exp 11/15/22 120038 exp 2/7/23
- Product
- Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Quantity
- 586 US; 694 OUS
- Distribution
- Worldwide distribution - US Nationwide.
- Recall date
- October 26, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)