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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm May 20, 2005
Date Posted November 18, 2005
Recall Status1 Terminated 3 on May 03, 2012
Recall Number Z-0171-06
Recall Event ID 32571
510(K)Number K041635  
Product Classification Assay, Glycosylated Hemoglobin - Product Code LCP
Product Product is in2it A1C In-Office Analyzer Test Cartridge. Catalogue number is 902074P (Test Cartridges) which may then be packaged as a consumables pack (902079D) or a starter pack (901077N). Product is labeled in part: ''in2it In-Office analyzer A1C Test Cartridges***For the rapid quantification of hemoglobin A1c in whole blood***Provalis Diagnostics***.''
Code Information Device Lot 03793, 03952, 04080, 04128, 04208, 04209, 04321, 04323, 04464, 05040.
Recalling Firm/
Manufacturer		 Provalis Diagnostics
7380 W Sand Lake Rd Ste 500
Orlando FL 32819-5257
Manufacturer Reason
for Recall		 Provalis Diagnostics discovered, following its internal stability testing program (mid-point batch testing), that occasional low values were being found across multiple lots of in2it HbA1C Test Cartridges.
FDA Determined
Cause 2		 Other
Action All consignees were initially notified by telephone with followup by FAX or email. Users/Distributors may also be visited by Provalis Sales Staff.
Quantity in Commerce 838 Kits of 10 test devices each
Distribution Distributed to 7 Consignees in the US one each in FL, KY, IL, LA, MI, AZ, GA.
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 = LCP and Original Applicant = PROVALIS DIAGNOSTICS LTD.
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