CLASS II Device recall · Reported 27 May 2020 · FDA Enforcement Report
The Optilite Clinical Chemistry Analyzer recalled
The Binding Site Group is recalling The Optilite Clinical Chemistry Analyzer, distributed nationwide in the US. The recall was initiated on 9 Apr 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2071-2020
- FDA event ID
- 85492
- Recalling firm
- The Binding Site Group, Birmingham, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Apr 2020
- FDA classified
- 21 May 2020
- Reported
- 27 May 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 9 Apr 2020 | Recall initiated by company | |
| 21 May 2020 | Classified by FDA | +42 days |
| 27 May 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A software issue that may affect the analyzer's result accuracy.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide AlabamaArkansasCaliforniaFloridaIllinoisIndianaKansasKentuckyMassachusettsMinnesotaNorth CarolinaNebraskaOhioPennsylvaniaTexasVirginia
Questions about this recall
Is The Optilite Clinical Chemistry Analyzer recalled?
Yes. The Binding Site Group recalled The Optilite Clinical Chemistry Analyzer on 9 Apr 2020. The recall is Class II and its status is Terminated. Recall number Z-2071-2020.
Why was it recalled?
A software issue that may affect the analyzer's result accuracy.
Which lots are affected?
Analyzers running with software version 7.0 or 7.01
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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