CLASS II Device recall · Reported 22 May 2013 · FDA Enforcement Report
Division iQ Control/Focus Set recalled by Iris Diagnostics
Iris Diagnostics is recalling Iris Diagnostics Division iQ Control/Focus Set, distributed nationwide in the US. The recall was initiated on 18 Sep 2012 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-1328-2013
- FDA event ID
- 64910
- Recalling firm
- Iris Diagnostics, Chatsworth, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Sep 2012
- FDA classified
- 15 May 2013
- Reported
- 22 May 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 18 Sep 2012 | Recall initiated by company | |
| 15 May 2013 | Classified by FDA | +239 days |
| 22 May 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The firm initiated this recall because complaints from customers reported that the recovery compared to assigned assay values is significantly below specification. This results in the instrument not passing controls and the customer not being able to run patient samples.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12. Product Usage: For in vitro diagnostic use with the iQ200 series.
Where it was distributed
Worldwide Distribution - USA Nationwide and the countries of: Canada, Malaysia, Spain, Switzerland, Taiwan, Peru, France, Russia, Japan, United Kingdom, Germany, and Paraguay.
Questions about this recall
Is Division iQ Control/Focus Set recalled?
Yes. Iris Diagnostics recalled Division iQ Control/Focus Set on 18 Sep 2012. The recall is Class II and its status is Terminated. Recall number Z-1328-2013.
Why was it recalled?
The firm initiated this recall because complaints from customers reported that the recovery compared to assigned assay values is significantly below specification. This results in the instrument not passing controls and the customer not being able to run patient samples.
Which lots are affected?
Part Number 800-3104. Lot Number 153-12. Expiration date: Jan 2013
Where was it sold?
Worldwide Distribution - USA Nationwide and the countries of: Canada, Malaysia, Spain, Switzerland, Taiwan, Peru, France, Russia, Japan, United Kingdom, Germany, and Paraguay.
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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