Recall Z-0747-2013 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
Alere San Diego, Inc.
Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88770 Alere Cholestech LDX Calibration Verification (hereafter referred to as CAL VERS) enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG), and glucose (GLU) test procedures on the Alere Cholestech LDX System. Calibration verification is optio
| Date | Jan 29, 2013 (initiated Oct 22, 2012) |
| Status | Terminated |
| Reason | Out of range (increased) HDL Cholesterol results. |
| Root cause | Component design/selection |
| Action | A recall letter was sent on 10/22/12 to all customers who purchased the Alere Cholestech LDX Mutianalyte Control, 2 vial set, Catalog Number 88769, Lot #C2510 & Lot #C2510A. The letter informed the customers that these lots of controls may yield results which are out of range high for the Level 2 control when tested with the Alere Cholestech LDX HDL test. Customers are instructed of the actions to be taken. On 11/16/12, the recall expanded to include the Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog 88770, Lot#271097. The problem identified is that these lots of calibr |
| Quantity | 614 kits |
| Distribution | Worldwide Distribution - USA (nationwide) Puerto Rico and South Korea. |
| 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 |