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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 Device Recall IRISpec" CA/CB twopart urine chemistry control twin setsee related information
Date Initiated by FirmJuly 09, 2012
Date PostedAugust 01, 2012
Recall Status1 Terminated 3 on January 27, 2014
Recall NumberZ-2124-2012
Recall Event ID 62555
510(K)NumberK945913 
Product Classification Urinalysis controls (assayed and unassayed) - Product Code JJW
ProductIRISpec" 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. 
FEI Number 2023446
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 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		Nonconforming Material/Component
ActionThe 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 Commerce862
DistributionNationwide Distribution
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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