Z-1018-2017Class II

Optilite Analyser

Name: Z-1018-2017 Optilite Analyser
Creator: The Binding Site Group, Ltd.
Published: 2015-05-13
License: https://open.fda.gov/license/

The Binding Site Group Ltd. / initiated 2015-05-13 / Terminated / root cause: design

FDA source

The Binding Site Group, Ltd. began a recall of Optilite Analyser, Product Code: IE700 Product Usage: The Thermo Scientific Indiko Clinical Chemistry Analyzer is a fully automated random access analyzer used... on 2015-05-13. FDA classified it as Class II and gives the reason as "Potential risk of the Optilite lid/cover falling suddenly and causing injury when not placed in the fully open position". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1018-2017
Classification: Class II
Status: Terminated
Initiated: 2015-05-13
Posted: 2017-01-13
Terminated: 2017-01-17
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.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: Potential risk of the Optilite lid/cover falling suddenly and causing injury when not placed in the fully open position.
Root cause tag: design
FDA 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 [email protected]
Quantity in commerce: 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.
Product codes and lots: 864000290243 864000290832 864000290244 864000290833 864000290330 864000290834 864000290447 864000290836 864000290448 864000290837 864000290449 864000290838 864000290452 864000290844 864000290826 864000290845 864000290827 864000290846 864000290828 864000290847 864000290831 864000290850

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1018-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1018-2017	Class II	Terminated	Voluntary: Firm initiated	2017-01-25	2017-01-13

Product code JJE

K110035Class IIndikoThermofisher Scientific OY / cleared 2011-06-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)