Iris Diagnostics Division iQ Control/Focus Set — Class II medical device recall Z-1328-2013
Terminated recall by Iris Diagnostics, reported 2013-05-22, distributed nationwide. The firm initiated this recall because complaints from customers reported that the recovery compared to assign
| Recall number | Z-1328-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Iris Diagnostics, Chatsworth, CA, United States |
| Recall initiated | 2012-09-18 |
| Classified | 2013-05-15 |
| Reported by FDA | 2013-05-22 |
| Terminated | 2014-01-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, CH, DE, ES, FR, GB, JP, MY, PE, PY, RU, TW |
| Quantity | 942 boxes |
| Reason classes | potency |
| Lot numbers | 153-12 |
| Model numbers | 800-3104 |
| Expiration dates | 2013-01-20 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1328-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.