Recall Z-1328-2013— Iris Diagnostics
Class II · Terminated
Class II FDA medical device recall by Iris Diagnostics, initiated 2012-09-18, terminated 2014-01-27. It names one FDA 510(k) clearance: K832713. 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..
- Recalling firm
- Iris Diagnostics
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-09-18
- Terminated
- 2014-01-27
- Firm location
- Chatsworth, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.