CLASS III Device recall · Reported 21 Oct 2015 · FDA Enforcement Report
Alere Cholestech LDX Multianalyte Controls, PN recalled
Alere San Diego is recalling Alere Cholestech LDX Multianalyte Controls, PN 88769 and 88773, distributed nationwide in the US. The recall was initiated on 27 Aug 2015 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-0122-2016
- FDA event ID
- 72120
- Recalling firm
- Alere San Diego, San Diego, CA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 27 Aug 2015
- FDA classified
- 15 Oct 2015
- Reported
- 21 Oct 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- E. coli
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 27 Aug 2015 | Recall initiated by company | |
| 15 Oct 2015 | Classified by FDA | +49 days |
| 21 Oct 2015 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
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 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.
Where it was distributed
Nationwide Distribution.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot C3091 and Lot C3091A
Where was it sold?
Nationwide Distribution.
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 26 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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| Device | ANNOUNCED | StatStrip Glucose Hospital Meter System recalled by Nova BiomedicalNova Biomedical StatStrip | Nova Biomedical | Device Malfunction | |
| Device | CLASS I | StatStrip Glucose Hospital Meter System recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |
| Device | CLASS I | StatStrip Glucose and B- Ketone meter recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |
| Device | CLASS I | StatStrip Glucose Hospital Meter System recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |
| Device | CLASS I | StatStrip Glucose and B- Ketone meter recalled by Nova Biomedical | Nova Biomedical | Device Malfunction | Nationwide |