Recall Z-0122-2016 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
Alere San Diego, Inc.
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.
| Date | Oct 15, 2015 (initiated Aug 27, 2015) |
| Status | Terminated |
| 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. |
| Root cause | Error in labeling |
| Action | Customer notification letters dated 8/25/15 and 9/3/15 were sent to customers to inform them that 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. Customers are informed that the Alere Cholestech LDX Total Cholesterol and Triglyceride assays continue to perform as expected. However, if customers' facility has used the control lot to test Total Cholesterol or Triglycerides as part of their Quality Control program, Alere San Diego recommends that they veri |
| Quantity | 190 kits |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102700 | LIPID CONTROLS; MULTI- ANALYTE CONTROL; MULTI-ANALYTE CALIBRATION VERIFICATION MATERIALS Alere, San Diego, Dba Biosite INcorporated, Dba IN, Dec 21, 2010 |