Recall Z-0104-2023 ยท NDW Assay, Porphyrin, Spectrophotometry, Lithium
Siemens Healthcare Diagnostics, Inc.
Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro diagnostic assay
| Date | Oct 20, 2022 (initiated Sep 19, 2022) |
| Status | Open, Classified |
| 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 lithium patient results, which may lead to inappropriate dosage adjustment, potentially affecting treatment efficacy. |
| Root cause | 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 | 1342 US; 2266 OUS |
| Distribution | Worldwide distribution - US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050374 | ADVIA IMS LITHIUM ASSAY Bayer Healthcare, LLC, Jun 15, 2005 |