Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported May 22, 2013
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.
The firm initiated this recall because complaints from customers reported that the recovery compared to assigned assay values is significantly below specification. This results i…
Iris Diagnostics recalled Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12. … - a moderate-severity action.
Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12. … was recalled by Iris Diagnostics in May 22, 2013. Reason: The firm initiated this recall because complaints from customers reported that the recovery compared to assi…. Check the official notice for the remedy. Verify recall #Z-1328-2013 with the FDA Devices before acting.
The recall
Iris Diagnostics issued this moderate-severity FDA Devices recall-The firm initiated this recall because complaints from customers reported that the recovery compared to assi….
- Moderate
- severity level
- Class II
- classification
- May 22, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1328-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1328-2013) was formally reported on May 22, 2013, with the manufacturer initiating the action on September 18, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Iris Diagnostics is listed as the recalling firm, operating out of Chatsworth, CA. Federal records list the affected scope as 942 boxes.
The documented reason for this recall is: 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 an… Distribution data in the federal record shows the product reached: Worldwide Distribution - USA Nationwide and the countries of: Canada, Malaysia, Spain, Switzerland, Taiwan, Peru, France, Russia, Japan, United Kingdom, Germany, and Paraguay.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
942 boxes
Related Recalls
6
3 from same agency
Product description
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.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1328-2013 |
| Date reported | May 22, 2013 |
| Date initiated | September 18, 2012 |
| Recalling firm | Iris Diagnostics |
| Firm location | Chatsworth, CA |
| Affected scope | 942 boxes |
| Distribution | Worldwide Distribution - USA Nationwide and the countries of: Canada, Malaysia, Spain, Switzerland, Taiwan, Peru, France, Russia, Japan, United Kingdom, Germany, and Paraguay. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1328-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Iris Diagnostics. Units affected: 942 boxes.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on May 22, 2013. Severity: Moderate. Recall number: Z-1328-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA Nationwide and the countries of: Canada, Malaysia, Spain, Switzerland, Taiwan, Peru, France, Russia, Japan, United Kingdom, Germany, and Paraguay..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1328-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 22, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.