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U.S. Department of Health and Human Services

Class 3 Device Recall IRISpec" CA/CB twopart urine chemistry control twin set

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 Class 3 Recall
IRISpec" CA/CB twopart urine chemistry control twin set
see related information
Date Posted August 01, 2012
Recall Status1 Terminated on January 27, 2014
Recall Number Z-2124-2012
Recall Event ID 62555
Premarket Notification
510(K) Number
K945913 
Product Classification Urinalysis Controls (Assayed And Unassayed) - Product Code JJW
Product IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074. Intended Use: IRISpec CA/CB is an assayed QC material for monitoring of the urine chemistry analytes and devices as listed on the package insert. For in vitro diagnostic (IVD) use only.
Code Information Iris Diagnostics part number 800-0074, lot number 131-12.
Recalling Firm/
Manufacturer
Iris Diagnostics
9172 Eton Ave
Chatsworth, California 91311-5805
Manufacturer Reason
for Recall
The firm recalled after it received complaints of IRISpec CA/CB two part Urine Chemistry Control, 101131-12, where the nitrite results read negative for the part B control, which should be positive.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action The firm initiated the recall on 07/09/12 by sending out a Medical Device Recall notification to customers via e-mail. The recall notification identified the affected product, reason for recall, and instructions on the recall. Customers were to confirm how many sets of unopened or partially opened IRISpec CA/CB that was in their inventory, dispose of the affected product, and provide written confirmation of the product's disposition. The letter also stated that Iris Diagnostics would replace any unused inventory that was returned at no charge to the customer. Contact information for the recall was also provided. The communications also included a fax response sheet for return/replacement.
Quantity in Commerce 862
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JJW and Original Applicant = INTERNATIONAL REMOTE IMAGING SYSTEMS
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