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U.S. Department of Health and Human Services

Class 2 Device Recall MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for SelfTesting & MultiPa

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 Class 2 Recall
MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for SelfTesting & MultiPa
see related information
Date Posted February 03, 2014
Recall Status1 Open
Recall Number Z-0910-2014
Recall Event ID 67152
Premarket Notification
510(K) Number
K032657 
Product Classification System, Test, Blood Glucose, Over The Counter - Product Code NBW
Product MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEtrack. Manufactured by: NIPRO DIAGNOSTICS, Fort Lauderdale, FL 33309 U.S.A. Is intended for the quantitative determination of glucose in human whole blood taken from finger or forearm.
Code Information Finished Goods: KJ0731; Lot Numbers: KK0964, KL01213, KL01233-3TI, KL0267-10, KL0381-14, KL0637-2TI, KL0716TI, KL0860TI, KP0074TI.
Recalling Firm/
Manufacturer
Nipro Diagnostics, Inc.
2400 NW 55th Ct
Ft Lauderdale, Florida 33309-2672
For Additional Information Contact Lisa Nardi
954-677-9201
Manufacturer Reason
for Recall
Manufactured with an incorrect factory set unit of measure.
FDA Determined
Cause 2
DESIGN: Software Design (Manufacturing Process)
Action Nipro Diagnostics sent an Urgent Medical Device Voluntary Recall letter dated December 31, 2013 to all affected customers. The customers were instructed to do the following: 1) Screen their inventory immediately for any of the serial numbers listed on the back of the products. 2) If they have any of the affected products, return the product by contacting Stericycle at 1-866-236-4518. 3) Complete and return the enclosed response form via fax at 1-888-358-7294. Customers with questions were instructed to call Stericycle at 1-866-236-4518. For questions regarding this recall call 954-677-9201.
Quantity in Commerce 105
Distribution Worldwide Distribution - USA (nationwide, HI and Puerto Rico and Internationally to Canada, European Union, Jamaica, Suriname, Trinidad and Tobago, Kazakhastan, Russian, Turkey, Australia, Bangladesh, Pakistan, Cambodia, Laos, Myanmar, Thailand, Vietnam, and India.
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 = NBW and Original Applicant = HOME DIAGNOSTICS, INC.
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