Recall – Clinical chemistry analyzer inaccurate results with certain software

Company: The Binding Site Group, Ltd.
Date of Enforcement Report: 6/10/2020
Class II

PRODUCT

The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051700017176 – Product Usage: The Optilite 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.

Recall Number: Z-2071-2020

REASON

A software issue that may affect the analyzer’s result accuracy.

RECALLING FIRM/MANUFACTURER

The Binding Site Group, Ltd. on 4/9/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

36

DISTRIBUTION

US Nationwide

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.