Recall Z-0747-2013— Alere San Diego, Inc.

Name: FDA recall Z-0747-2013
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 Calibration Verification, 4 vial set, Catalog Number: 88770 Alere Cholestech LDX Calibration Verification (hereafter referred to as CAL VERS) enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG), and glucose (GLU) test procedures on the Alere Cholestech LDX System. Calibration verification is optional for CLIA waived systems, such as the Alere Cholestech LDX System, under CLIA regulations. However local or state regulations may require that calibration verification is run at regular intervals.. 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 Calibration Verification, 4 vial set, Catalog Number: 88770 Alere Cholestech LDX Calibration Verification (hereafter referred to as CAL VERS) enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG), and glucose (GLU) test procedures on the Alere Cholestech LDX System. Calibration verification is optional for CLIA waived systems, such as the Alere Cholestech LDX System, under CLIA regulations. However local or state regulations may require that calibration verification is run at regular intervals.

Reason for recall

Out of range (increased) HDL Cholesterol results.

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