FDA Medical Device Recalls (openFDA)
The Binding Site Group, Ltd.: 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.
- Recall number
- Z-1018-2017
- Recalling firm
- The Binding Site Group, Ltd.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2015-05-13
- Posted
- not on file
- Terminated
- 2017-01-17
- Reason
- Potential risk of the Optilite lid/cover falling suddenly and causing injury when not placed in the fully open position.
- Root cause
- Component design/selection
- Action
- Binding Site sent an Urgent Field Safety Notice letter dated May 13, 2015 to their customers The letter identified the affected product, problem and actions to be taken. Customers are instructed to complete and return the Eback Form that this notice has been received and the actions to be taken have been completed to technical.services@bindingsite.co.uk
- Quantity
- 129 units
- Distribution
- 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.
- Lot, serial or model codes
- 864000290243 864000290832 864000290244 864000290833 864000290330 864000290834 864000290447 864000290836 864000290448 864000290837 864000290449 864000290838 864000290452 864000290844 864000290826 864000290845 864000290827 864000290846 864000290828 864000290847 864000290831 864000290850
- 510(k) numbers
- ["K110035"]
- PMA numbers
- not on file
- Product code
- JJE
- Firm FEI
- 3002808340
- Firm city
- Birmingham
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28