Alere San Diego Clearview MONO recall — FDA Z-2267-2016
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
Overview of recall records associated with Alere San Diego, Inc., including dates, categories and classifications where available.
Classification mix: Class III: 9, Class I: 9, Class II: 8.
The Positive Control information referencing human plasma as the antibody material described in the product labeling and packaging is incorrect.
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.
This page summarizes recall records in which the official source identifies Alere San Diego, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.