CLASS II Device recall · Reported 25 Jan 2017 · FDA Enforcement Report
Optilite Analyser, Product recalled by The Binding Site Group
The Binding Site Group is recalling Optilite Analyser, distributed nationwide in the US. The recall was initiated on 13 May 2015 and the FDA has classified it as Class II.
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-1018-2017
- FDA event ID
- 75898
- Recalling firm
- The Binding Site Group, Birmingham
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 May 2015
- FDA classified
- 13 Jan 2017
- Reported
- 25 Jan 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 13 May 2015 | Recall initiated by company | |
| 13 Jan 2017 | Classified by FDA | +611 days |
| 25 Jan 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential risk of the Optilite lid/cover falling suddenly and causing injury when not placed in the fully open position.
Product as listed by the FDA
Optilite Analyser, Product Code: IE700 Product Usage: The Thermo Scientific Indiko Clinical Chemistry Analyzer is a fully automated random access analyzer used to measure a variety of analytes that may be adaptable to the analyzer depending on the reagent used. The Indiko Glucose (H-K) test system, is intended for in vitro diagnostic use in the quantitative determination of the glucose concentration in human plasma on the Indiko analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemnia, and of pancreatic islet cell carcinoma.
Where it was distributed
Worldwide Distribution - US Nationwide in the states of: CA, VA, GA, PA, NJ, KY, NY, AR, NM, NC, AL, GA, MI, and the countries of Canada, China, Australia, Israel, Ireland, UK, Germany, Belgium, Italy, France, Czech republic, Spain, Portugal.
Nationwide AlabamaArkansasCaliforniaGeorgiaKentuckyMichiganNorth CarolinaNew JerseyNew MexicoNew YorkPennsylvaniaVirginia
Questions about this recall
Why was it recalled?
Potential risk of the Optilite lid/cover falling suddenly and causing injury when not placed in the fully open position.
Which lots are affected?
864000290243 864000290832 864000290244 864000290833 864000290330 864000290834 864000290447 864000290836 864000290448 864000290837 864000290449 864000290838 864000290452 864000290844 864000290826 864000290845 864000290827 864000290846 864000290828 864000290847 864000290831 864000290850
Where was it sold?
Worldwide Distribution - US Nationwide in the states of: CA, VA, GA, PA, NJ, KY, NY, AR, NM, NC, AL, GA, MI, and the countries of Canada, China, Australia, Israel, Ireland, UK, Germany, Belgium, Italy, France, Czech republic, Spain, Portugal.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
More recalls from The Binding Site Group
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|---|---|---|---|---|---|
| Device | CLASS II | Exent Analyser recalled by The Binding Site Group | The Binding Site Group | Potency & Assay | Nationwide |
| Device | CLASS II | Freelite Human Lambda Free Kit (for use on the Spaplus) recalled | The Binding Site Group | Other | 13 states |
| Device | CLASS II | Freelite Human Kappa Free Kit recalled by The Binding Site Group | The Binding Site Group | Other | Nationwide |
| Device | CLASS II | Optilite Freelite Mx Kappa Free Kit recalled by The Binding Site Group | The Binding Site Group | Other | 10 states |
| Device | CLASS II | Optilite Rheumatoid Factor Kit recalled by The Binding Site Group | The Binding Site Group | Other | 20 states |
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| Device | CLASS II | Fisher Scientific Sure-Vue Urine hCG Strip recalled by Alere San Diego | Alere San Diego | Potency & Assay | Nationwide |
| 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 |