Reported Feb 6, 2013 · Terminated
Alere Cholestech LDX Multianalyte Control, 2 vial set, Catalog Number: 88769 Alere Cholestech LDX Multianalyte Control…
Alere San Diego, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Alere San Diego, Inc. · 9975 Summers Ridge Rd · San Diego, CA · 92121-2997
Is this the product you have?
- Alere Cholestech LDX Multianalyte Control, 2 vial set
- Catalog Number88769 Alere Cholestech LDX Multianalyte Control (hereafter referred to as Controls) enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG), glucose (GLU), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) test procedures on the Alere Cholestech LDX System. The results obtained for the controls are to be compared with the assigned values given on the Expected Values Card, accompanying the package insert, to determine if the procedure is within control limits. Assayed quality control material for use with the Alere Cholestech LDX System
- Lot codes and dates
Lot#C2510C2510AC2572C2572AC2593and C2593A
- Amount recalled
- 11,166 kits
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Out of range (increased) HDL Cholesterol results.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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