Exact FDA event identifier

Event 85492

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: April 09, 2020
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: The Binding Site Group, Ltd.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-2071-2020

Recall number: Z-2071-2020
Initiated: April 09, 2020
Classification: Class II
Status: Terminated
Recalling firm: The Binding Site Group, Ltd.
Quantity: 36

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0

software issue

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Analyzers running with software version 7.0 or 7.01

Distribution pattern

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.