Reported Feb 6, 2013 · Terminated
Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88770 Alere Cholestech LDX Calibration…
Alere San Diego, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Alere San Diego, Inc. · 9975 Summers Ridge Rd · San Diego, CA · 92121-2997
Is this the product you have?
- Alere Cholestech LDX Calibration Verification, 4 vial set
- Catalog Number88770 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
- Lot codes and dates
Lot#271097298148and 301886
- Amount recalled
- 614 kits
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Out of range (increased) HDL Cholesterol results.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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