Recall Z-1018-2017— The Binding Site Group, Ltd.

Name: FDA recall Z-1018-2017
Creator: U.S. Food and Drug Administration
Published: 2015-05-13

Class II · Terminated

Class II FDA medical device recall by The Binding Site Group, Ltd., initiated 2015-05-13, terminated 2017-01-17. It names one FDA 510(k) clearance: K110035. 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.. Reason: Potential risk of the Optilite lid/cover falling suddenly and causing injury when not placed in the fully open position..

Recalling firm: The Binding Site Group, Ltd.
Classification: Class II
Status: Terminated
Initiated: 2015-05-13
Terminated: 2017-01-17
Firm location: Birmingham, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K110035 — INDIKOThermofisher Scientific OY·cleared 2011-06-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Potential risk of the Optilite lid/cover falling suddenly and causing injury when not placed in the fully open position.

Data sourced from openFDA. This site is unofficial and independent of the FDA.