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U.S. Department of Health and Human Services

Class 3 Device Recall MAS Urinalysis

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  Class 3 Device Recall MAS Urinalysis see related information
Date Initiated by Firm October 29, 2013
Date Posted November 22, 2013
Recall Status1 Terminated 3 on March 17, 2014
Recall Number Z-0383-2014
Recall Event ID 66739
510(K)Number K973451  
Product Classification Urinalysis controls (assayed and unassayed) - Product Code JJW
Product MAS Urinalysis Control Level 1, Multi-analyte control (Assayed and Unassayed), Catalog/Part Numbers: 024222; Product is manufactured and distributed by Microgenics Corporation, a subsidiary of Thermo Fisher Scientific, Clinical Diagnostic Division, Fremont, CA

MAS Urinalysis is intended for use in the clinical laboratory as a control for qualitative and semi-quantitative procedures used in routine urinalysis testing. Assay values are provided for specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and equipment. The product is suitable for use as a control material for physiochemical, chemical, and microscopic methods of routine urinalysis. Urinalysis may be used in conjunction with commercially available standardized systems for urine microscopic analysis.
Code Information Lot Number: UA1514011
Recalling Firm/
Manufacturer		 Thermofisher Scientive
46360 Fremont Blvd
Fremont CA 94538-6406
Manufacturer Reason
for Recall		 Via one (1) consumer complaint and in-house testing has confirmed that the product does not meet the 30 day open vial stability specifications for Lot: UA1514011.
FDA Determined
Cause 2		 Under Investigation by firm
Action ThermoFisher Scientific, sent an Urgent Medical Device Field Correction letter dated October 29, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use, segregate and discard the affected product. Customers with questions were instructed to contact mas.controls@thermofisher.com. For question regarding this recall call 1-800-232-3342.
Quantity in Commerce 914 units
Distribution Worldwide Distribution - USA (nationwide) including Puerto Rico and internationally to Hong Kong.
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 = JJW and Original Applicant = MEDICAL ANALYSIS SYSTEMS, INC.
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