Lower riskMedical device recall · FDA · Published April 9, 2020
The Optilite Clinical Chemistry Analyzer Software Issue May Affect Test Accuracy
The Binding Site recalls The Optilite Clinical Chemistry Analyzer (model IE700) due to a software issue that may affect test result accuracy. Affected units run software versions 7.0 or 7.01.
“The Optilite Clinical Chemistry Analyzer Software Issue May Affect Test Accuracy.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65455-the-optilite-clinical-chemistry-analyzer-software-issue-may-affect-test. Based on FDA recall #Z-2071-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2071-2020%22&limit=1).
The Food and Drug Administration announced on April 9, 2020, that The Binding Site Group, Ltd. recalled The Optilite Clinical Chemistry Analyzer due to a software issue affecting result accuracy. The agency classified the recall as Class II.
How to tell if you have it
Brand: The Binding Site
Product: The Optilite Clinical Chemistry Analyzer
Model Number: IE700
UDI: 05051700017176
Software versions: 7.0 or 7.01
The hazard
The recall involves a software issue that may affect the analyzer's result accuracy, according to the FDA.
Context
GovInfoNow's records show The Binding Site Group, Ltd. has 15 other recalls on record since 2017-08-23. Other recent recalls of similar products include DxC 500i Clinical Analyzer Modules May Show Incorrect Test Results Due to Software Issue (2026-09-02), Beckman Coulter AU5800 Chemistry Analyzer Recall: Delay in Results Risk (2026-01-30), and AU480 Chemistry Analyzer May Show Error Message Causing Delay in Patient Results (2026-08-03).
How to tell if you have this one
Check if your analyzer has model number IE700 and software version 7.0 or 7.01. The product is used in clinical laboratories for blood and other clinical tests.
Brand
The Binding Site
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Update Software
Contact The Binding Site to update to a newer software version that resolves the issue.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 16 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arkansas, California, Florida, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Minnesota, Nebraska, North Carolina, Ohio, Pennsylvania, Texas, Virginia.
Recall timeline
FDA terminated this recall 2.4 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2071-2020 (April 9, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2071-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.