FDA Device recall Z-0122-2016
Alere Cholestech LDX Multianalyte Controls, PN 88769 and 88773
- FDA Device
- Class III
- terminated
- Published 2015-10-21
On 2015-10-21 the FDA classified a Class III recall of Alere Cholestech LDX Multianalyte Controls, PN 88769 and 88773 by Alere San Diego, citing alere San Diego is recalling the Alere Cholestech LDX Multianalyte Control because the assigned control ranges for the Total Cholesterol (TC) and Triglyceride (TRG) analytes are i….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0122-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-08-27 |
| Published | 2015-10-21 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Alere San Diego |
| Distribution | US |
Product
Alere Cholestech LDX Multianalyte Controls, PN 88769 and 88773. Enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG) and glucose (GLU) test procedures.
Reason
Alere San Diego is recalling the Alere Cholestech LDX Multianalyte Control because the assigned control ranges for the Total Cholesterol (TC) and Triglyceride (TRG) analytes are incorrect.
Identifiers
| code_info | Lot C3091 and Lot C3091A |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0122-2016%22
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