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U.S. Department of Health and Human Services

Class 3 Device Recall

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 Class 3 Device Recallsee related information
Date Initiated by FirmApril 29, 2005
Date PostedJune 11, 2005
Recall Status1 Terminated 3 on May 07, 2012
Recall NumberZ-0884-05
Recall Event ID 32036
510(K)NumberK945913 
Product Classification Urinalysis Controls (Assayed And Unassayed) - Product Code JJW
ProductIRISpec CA/ IRISpec CB Two-Part Urine Chemistry Control Twin Set, part no. 800-0074.
Code Information Lot No. 103-05
FEI Number 2023446
Recalling Firm/
Manufacturer		 International Remote Imaging Systems Inc
9172 Eton Ave
Chatsworth CA 91311-5805
For Additional Information ContactGerald J Haddock
818-709-1244 Ext. 129
Manufacturer Reason
for Recall		Nonconformance to performance specifications.
FDA Determined
Cause 2		Other
ActionFirm telephoned customers April 29, 2005 requesting return of product. All customers were contacted as of May 4, 2005.
Quantity in Commerce107
DistributionNationwide.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JJW
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