Recall Z-0964-2012 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
Alere San Diego
Alere Cholestech LDX Analyzer, Model Number: 10-004, 14-874, 14-875, in vitro diagnostic.
| Date | Feb 6, 2012 (initiated Nov 16, 2010) |
| Status | Terminated |
| Reason | Alere has identified that a bias on results for certain analytes tested on the Alere Cholestech LDX System may exist due to humidity variability. |
| Root cause | Device Design |
| Action | Alere sent an Updated Urgent Recall Notification Letter in March 2012 to all their customers who are in possession of one or more Cholestech LDX Systems. The updated letter provides the customers with important information about the problem identified and the actions to be taken. Customers are instructed to operate their device in a controlled environment that maintains humidity within 40-60% relative humidity if the device has not been upgraded with ROM pack v3.40. If humidity cannot be monitored, the device is no longer CLIA waived. Customers are instructed to complete the customer verifi |
| Quantity | 22,000 meters |
| Distribution | Worldwide distribution including USA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K901900 | L.D.X LIPID MONITORING SYSTEM Cholestech Corp., Jul 24, 1990 |