Recall Z-0746-2013— Alere San Diego, Inc.

Name: FDA recall Z-0746-2013
Creator: U.S. Food and Drug Administration
Published: 2012-10-22

Class III · Terminated

Class III FDA medical device recall by Alere San Diego, Inc., initiated 2012-10-22, terminated 2013-09-26. It names one FDA 510(k) clearance: K102700. Product: Alere Cholestech LDX Multianalyte Control, 2 vial set, Catalog Number: 88769 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.. Reason: Out of range (increased) HDL Cholesterol results..

Recalling firm: Alere San Diego, Inc.
Classification: Class III
Status: Terminated
Initiated: 2012-10-22
Terminated: 2013-09-26
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 Control, 2 vial set, Catalog Number: 88769 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.

Reason for recall

Out of range (increased) HDL Cholesterol results.

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