Recall Z-0122-2016— Alere San Diego, Inc.

Name: FDA recall Z-0122-2016
Creator: U.S. Food and Drug Administration
Published: 2015-08-27

Class III · Terminated

Class III FDA medical device recall by Alere San Diego, Inc., initiated 2015-08-27, terminated 2015-12-22. It names one FDA 510(k) clearance: K102700. Product: 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.. Reason: 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..

Recalling firm: Alere San Diego, Inc.
Classification: Class III
Status: Terminated
Initiated: 2015-08-27
Terminated: 2015-12-22
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K102700 — LIPID CONTROLS; MULTI- ANALYTE CONTROL; MULTI-ANALYTE CALIBRATION VERIFICATION MATERIALSAlere, San Diego, Dba Biosite INcorporated, Dba IN·cleared 2010-12-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.