Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall MAS Urinalysis

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 3 Device Recall MAS Urinalysissee related information
Date Initiated by FirmOctober 29, 2013
Date PostedNovember 22, 2013
Recall Status1 Terminated 3 on March 17, 2014
Recall NumberZ-0383-2014
Recall Event ID 66739
510(K)NumberK973451 
Product Classification Urinalysis controls (assayed and unassayed) - Product Code JJW
ProductMAS 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
ActionThermoFisher 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 Commerce914 units
DistributionWorldwide Distribution - USA (nationwide) including Puerto Rico and internationally to Hong Kong.
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
-
-