Recall Z-1328-2013 ยท JJW Urinalysis Controls (Assayed And Unassayed)
Iris Diagnostics
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.
| Date | May 15, 2013 (initiated Sep 18, 2012) |
| Status | Terminated |
| 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. |
| Root cause | Nonconforming Material/Component |
| Action | IRIS sent a Medical Device Recall letter dated September 18, 2012 to all affected customers. The letter identified the affected product, problem, and actions to be taken. Customers were instructed to dispose of all unopened or partially used inventory, complete the attached worksheet certifying the disposal of the affected product and email or fax to Iris Diagnostics. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K832713 | IRI SPEC URINALYSIS CONTROL Intl. Remote Imaging Systems, Dec 22, 1983 |