Device 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.
Z-0122-2016
Product summary
- Event
- Event 72120
- Status
- Terminated
- Classification
- Class III
- Quantity
- 190 kits
- Official record key
device-enforcement:Z-0122-2016
Official wording
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.
Code information: Lot C3091 and Lot C3091A
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
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.