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 Tosoh

  • 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 Tosohsee related information
Date Initiated by FirmAugust 18, 2005
Date PostedNovember 15, 2005
Recall Status1 Terminated 3 on August 25, 2006
Recall NumberZ-0131-06
Recall Event ID 33199
510(K)NumberK952720 
Product Classification Mixture, Hematology Quality Control - Product Code JPK
ProductTosoh brand Glycohemoglobin A1c Controls I & II, Catalog Number: 992133; Product is distributed by TOSOH Bioscience Inc., 347 Oyster Point Blvd. Suite 201, South San Francisco, CA 94080.
Code Information Kit Lot Number: 31205; Controls I & II Lot Numbers: 31009AA, 31010AA 
FEI Number 1000123732
Recalling Firm/
Manufacturer		 Tosoh Bioscience, Inc.
347 Oyster Point Blvd Ste 201
South San Francisco CA 94080-1913
Manufacturer Reason
for Recall		The firm has received reports that vials of the Level II were exhibiting poor and inconsistent chromatogram quality thus affecting control results.
FDA Determined
Cause 2		Other
ActionOn August 18, 2005, the firm initiated the recall and issued notification to its consignees via mail, including instructions for distributors of the recall.
Quantity in Commerce3,284 boxes
DistributionThe product was distributed to a total of 384 consignees throughout the US as well as Canada, Puerto Rico, Chile and Brazil.
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 = JPK
-
-