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U.S. Department of Health and Human Services

Class 2 Device Recall iChem 10 SG Urine Chemistry Strips

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  Class 2 Device Recall iChem 10 SG Urine Chemistry Strips see related information
Date Initiated by Firm December 08, 2014
Create Date January 13, 2016
Recall Status1 Terminated 3 on January 13, 2016
Recall Number Z-0649-2016
Recall Event ID 72925
510(K)Number K060280  
Product Classification Method, enzymatic, glucose (urinary, non-quantitative) - Product Code JIL
Product iChem 10 SG Urine Chemistry Strips, PN 800-7005.

Intended for the in vitro measurement of glucose, protein, bilirubin, urobilinogen, pH, specific gravity, blood, ketones, nitrite, leukocyte esterase, ascorbic acid, and color.
Code Information 510033A, expiration 2015-03 510034A, expiration 2015-04 510035A, expiration 2015-07 510035B, expiration 2015-09
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
Manufacturer Reason
for Recall		 Iris International is recalling the iChem 10 SG Urine Chemistry Strip because of false positive leukocyte result for samples that are truly negative.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action An "Important Product Notice," dated 12/8/14 was sent to customers to inform them of the recall by Iris International. The recall letter informs customers that The identified lots of iChem 10 SG Urine Chemistry Strips may have leukocyte pads that are more sensitive at the first reporting range of 1+, corresponding to 25 white blood cells (WBCs) /microliter. The letter provides the impact of the recall and the actions to taken by the customers. Customers are instructed to discard any remaining strips from the affected lots and use another lot number. Customers can either contact their local Customer Service Support or complete and return the Replacement Order form, if replacement product is needed. The enclosed response form should be completed and returned within 10 days. Customers with questions are instructed to refer to http://www.beckmancoulter.com; (800) 854-3633 in US and Canada. Customers outside the US and Canada are instructed to contact their local support representative.
Quantity in Commerce 16,206 vials total (7,827 vials in US)
Distribution Worldwide Distribution -- US, Brazil, Canada, Chile, Ecuador, France, Germany, Greece, Italy, Kuwait, Luxembourg, Malaysia, Philippines, Portugal, Puerto Rico, Singapore, Spain, Switzerland, Turkey, and United Arab Emirates.
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 = JIL and Original Applicant = IRIS INTERNATIONAL, INC.
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