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U.S. Department of Health and Human Services

Class 2 Device Recall Iris Diagnostics Division iQ Control/Focus Set

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  Class 2 Device Recall Iris Diagnostics Division iQ Control/Focus Set see related information
Date Initiated by Firm September 18, 2012
Date Posted May 15, 2013
Recall Status1 Terminated 3 on January 27, 2014
Recall Number Z-1328-2013
Recall Event ID 64910
510(K)Number K832713  
Product Classification Urinalysis controls (assayed and unassayed) - Product Code JJW
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.
Code Information Part Number 800-3104. Lot Number 153-12. Expiration date: Jan 2013
Recalling Firm/
Manufacturer		 Iris Diagnostics
9172 Eton Ave
Chatsworth CA 91311-5805
For Additional Information Contact
818-709-1244
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JJW and Original Applicant = INTL. REMOTE IMAGING SYSTEMS
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