FDA Device recall Z-1328-2013
Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12
- FDA Device
- Class II
- terminated
- Published 2013-05-22
On 2013-05-22 the FDA classified a Class II recall of Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12 by Iris Diagnostics, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1328-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-09-18 |
| Published | 2013-05-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Iris Diagnostics |
| Distribution | US |
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
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.
Identifiers
| code_info | Part Number 800-3104. Lot Number 153-12. Expiration date: Jan 2013 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1328-2013%22
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