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.
- Company
- Alere San Diego, Inc.
- Recall Initiated
- August 27, 2015
- Posted
- October 15, 2015
- Terminated
- December 22, 2015
- Recall Number
- Z-0122-2016
- Quantity
- 190 kits
- Firm Location
- San Diego, CA
Reason for Recall
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.
Distribution
Nationwide Distribution.
Lot / Code Info
Lot C3091 and Lot C3091A
Root Cause
Error in labeling
Action Taken
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 verify previous results or perform control testing using the replacement Expected Value Card or replacement control materials. The letters also provide customers with actions to be taken. Customers with questions are instructed to contact: Alere San Diego, Inc. 9975 Summers Ridge Road San Diego, CA 92121 U.S.A. Phone: 877-308-8289, FAX: 866-333-9839, E-mail: Verifications.ts@alere.com.