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 Kallestad (TM) HEp2

  • 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 Kallestad (TM) HEp2 see related information
Date Initiated by Firm July 29, 2008
Date Posted September 19, 2008
Recall Status1 Terminated 3 on March 31, 2011
Recall Number Z-2430-2008
Recall Event ID 49083
510(K)Number K792610  
Product Classification Multiple Autoantibodies - Product Code DBL
Product Kallestad (TM) Mouse Kidney. Product labeled "BIO-RAD Kallestad (TM) Mouse Kidney Substrate... UNITED STATES, Bio-Rad Laboratories, Redmond, WA 98052... FRANCE, Bio-Rad Laboratories, 92430 Marnes La Coquette". Catalog numbers: 30445 - 8 wells, 48 tests and 30447 - 8 well, 192 tests.
Code Information Lot # and exp: for catalog # 30445 - 951563, exp 11/30/08; 953560, exp 1/31/09; and 955471, exp 4/30/09; for catalog # 30447 - 951565, exp 11/30/08; 953561, exp 1/31/09; and 954607, exp 3/31/09.
Recalling Firm/
Manufacturer		 Bio-Rad Laboratories
6565 185th Ave NE
Redmond WA 98052-5039
For Additional Information Contact Daniel E Bennett
425-498-1805
Manufacturer Reason
for Recall		 The Homogeneous Positive control was released with a titer of 1:256 rather than the titer value of 1:128 reported on the QC Report Label included with each test kit.
FDA Determined
Cause 2		 Employee error
Action On 7/25/08, the firm began to notify their customers about the recall via an Urgent Product Correction sent by DHL or FEDEX. Included with the customer letter was a revised QC Card. International subsidiaries were notified by e-mail with the customer letter and revised QC Card attached. The letter informed customers of the recall and directing them to the revised QC card which was attached to the letter. The instructions are to, "Please use this to replace the card in any kits remaining in your facility." If customers have any questions or require additional QC cards, they are to contact Technical Support.
Quantity in Commerce 69 total kits
Distribution Worldwide Distribution --- including USA and countries of AUSTRALIA, BRAZIL, CANADA, CHINA , FRANCE, GERMANY, HONG KONG, INDIA, ITALY, JAPAN, MEXICO, NEW ZEALAND, POLAND, SINGAPORE, SOUTH KOREA , TAIWAN, UNITED KINGDOM, and URUGUAY.
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 = DBL and Original Applicant = KALLESTAD LABORATORIES, INC.
-
-