FDA Device recall Z-1268-2023
Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative determination of LDL cholesterol in human serum and plasma (lith…
- FDA Device
- Class II
- ongoing
- Published 2023-09-06
On 2023-09-06 the FDA classified a Class II recall of Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative determination of LDL cholesterol in human serum and plasma (lith… by Siemens Healthcare Diagnostics, citing reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1268-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-01-27 |
| Published | 2023-09-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Healthcare Diagnostics |
| Distribution | US |
Product
Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative determination of LDL cholesterol in human serum and plasma (lithium heparin) using the Atellica CH Analyzer. SMN: 11097632
Reason
Reagent Carryover from LDL Cholesterol Direct (DLDL), Total Protein II (TP), Triglycerides (Trig), and Triglycerides_2 (Trig_2) Impacting Magnesium (Mg) Results
Identifiers
| code_info | UDI: 00630414596181 All Lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1268-2023%22
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