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 2 Device Recall IMUBIND Plasma PAI1 ELISA Kit, MODEL 822

  • 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 2 Device Recall IMUBIND Plasma PAI1 ELISA Kit, MODEL 822see related information
Date Initiated by FirmMarch 05, 2010
Date PostedApril 21, 2010
Recall Status1 Terminated 3 on July 29, 2016
Recall NumberZ-1426-2010
Recall Event ID 54858
510(K)NumberK013168 
Product Classification test, qualitative and quantitative factor deficiency - Product Code GGP
ProductREF 822 IMUBIND(R) Plasma PAI-1 ELISA The intended use: Product is an enzyme-linked immunosorbent assay for the quantative measurement of human Plasminogen Activator Inhibitor Type-1 (PA-1) antigen in plasma.
Code Information REF 822 lot 102401 CPT Code 85400 expires on 2010NOV24
Recalling Firm/
Manufacturer		 American Diagnostica, Inc.
500 West Ave
Stamford CT 06902
For Additional Information Contact
203-602-7777
Manufacturer Reason
for Recall		Unacceptable microwell to microwell variation in the section of the plate that is typically used for the calibrators
FDA Determined
Cause 2		Process control
ActionThree emails "REF 822 lot 102401 needs to be recalled" dated March 1, 2010 was sent to three customers. The emails described the product, problem and action to be taken by the customers. The customers should send the kit to the firm (SEKISUI american diagnostica inc.) attention of Leigh Ayres, Director, Regulatoy Affairs and Quality Assurance. If you have any question, please call 1-203-602-7777.
Quantity in Commerce25 kits
DistributionWorldwide distribution: USA and UK, Taiwan and Korea.
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 = GGP
-
-