Z-2071-2020Class II

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

Name: Z-2071-2020 The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051700017176 -
Creator: The Binding Site Group, Ltd.
Published: 2020-04-09
License: https://open.fda.gov/license/

The Binding Site Group Ltd. / initiated 2020-04-09 / Terminated / root cause: software

FDA source

The Binding Site Group, Ltd. began a recall of The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051700017176 - Product Usage: The Optilite Clinical Chemistry Analyzer is a fully... on 2020-04-09. FDA classified it as Class II and gives the reason as "A software issue that may affect the analyzer's result accuracy". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2071-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-09
Posted: 2020-05-21
Terminated: 2022-08-19
Recalling firm: The Binding Site Group Ltd.
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.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: A software issue that may affect the analyzer's result accuracy.
Root cause tag: software
FDA root cause: Software design
Action: The field safety notice has been issued from The Binding Site UK office to The Binding Site US office. The Binding Site US office will notify affected end users in the US. An e-back form will be provided to affected customers along with the FSN. The FSN requests the customer to complete, sign and return the e-back form to The Binding Site to confirm that they have received and understood the FSN.
Quantity in commerce: 36
Distribution: US Nationwide distribution including in the states of AL, AR, CA, FL, IL, IN, KS, KY, MA, MN, NC, NE, OH, PA, TX and VA.
Product codes and lots: Analyzers running with software version 7.0 or 7.01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2071-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2071-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-21

Product code JJE

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)