Alere San Diego, Inc. recalls Alere Cholestech LDX Multianalyte Controls, PN 88769 and 88773. Enables users to monitor the performance of total chole…
- Recall date
- August 27, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0122-2016
- FDA classification
- Class III
- Brand / firm
- Alere San Diego, Inc.
- Sold / distributed
- Nationwide Distribution.
Why it was recalled
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.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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.
Get recall alerts
Free email alert whenever Alere San Diego, Inc. has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Alere San Diego, Inc.