Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12. Product Usage: For in vitro dia
FDA device recall Z-1328-2013 · posted 2013-05-15 · Terminated
Recall details
- Recalling firm
- Iris Diagnostics
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JJW
- Quantity affected
- 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.
- Date initiated
- 2012-09-18
- Date posted
- 2013-05-15
- Date terminated
- 2014-01-27
- Location
- Chatsworth, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IRI SPEC URINALYSIS CONTROL (K832713) | Intl. Remote Imaging Systems | 1983-12-22 |