Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro diagnostic assay
FDA device recall Z-0104-2023 · posted 2022-10-20 · Open, Classified
Recall details
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- NDW
- Quantity affected
- 1342 US; 2266 OUS
- Distribution
- Worldwide distribution - US Nationwide.
- Date initiated
- 2022-09-19
- Date posted
- 2022-10-20
- Location
- Tarrytown, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ADVIA IMS LITHIUM ASSAY (K050374) | Bayer Healthcare, LLC | 2005-06-15 |