CLASS III Device recall · Reported 6 Feb 2013 · FDA Enforcement Report
Alere Cholestech LDX Calibration Verification, 4 vial set recalled
Alere San Diego is recalling Alere Cholestech LDX Calibration Verification, 4 vial set, distributed nationwide in the US. The recall was initiated on 22 Oct 2012 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0747-2013
- FDA event ID
- 63918
- Recalling firm
- Alere San Diego, San Diego, CA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 22 Oct 2012
- FDA classified
- 29 Jan 2013
- Reported
- 6 Feb 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- E. coli
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 22 Oct 2012 | Recall initiated by company | |
| 29 Jan 2013 | Classified by FDA | +99 days |
| 6 Feb 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Out of range (increased) HDL Cholesterol results.
Some strains of E. coli, such as O157:H7, produce a toxin that can cause severe stomach cramps, bloody diarrhea and, in a small number of cases, kidney failure.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution - USA (nationwide) Puerto Rico and South Korea.
Questions about this recall
Is Alere Cholestech LDX Calibration Verification, 4 vial set recalled?
Yes. Alere San Diego recalled Alere Cholestech LDX Calibration Verification, 4 vial set on 22 Oct 2012. The recall is Class III and its status is Terminated. Recall number Z-0747-2013.
Why was it recalled?
Out of range (increased) HDL Cholesterol results.
Which lots are affected?
Lot#271097, 298148, and 301886
Where was it sold?
Worldwide Distribution - USA (nationwide) Puerto Rico and South Korea.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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