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U.S. Department of Health and Human Services

Class 3 Device Recall Rabbit Kidney Culture

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  Class 3 Device Recall Rabbit Kidney Culture see related information
Date Initiated by Firm January 21, 2009
Date Posted February 24, 2010
Recall Status1 Terminated 3 on September 21, 2010
Recall Number Z-0822-2010
Recall Event ID 53702
Product Classification Cells, animal and human, cultured - Product Code KIR
Product Rabbit Kidney Culture, brand name: 'FreshCells'. The product is labeled as 'Rabbit Kidney' also known as 'Rbk' , 2-square cm area of a cell monolayer covered with 2-mL culture medium. The product is packed in glass culture tubes 16x125mm, with screw caps. The product is distributed in EPS shipping racks which can hold up to 50 tubes each.

Used routinely for in vitro diagnostic testing for virus and/or Chlamydia isolation and to aid in the diagnosis of diseases associated with infectious agents.
Code Information Catalog Number: 48-0600, Lot #480109.
Recalling Firm/
Manufacturer		 Diagnostic Hybrids Inc
1055 East State Street
Suite 100
Athens OH 45701-1526
For Additional Information Contact
740-589-3300
Manufacturer Reason
for Recall		 During QC post release monitoring, the firm determined that the monolayer culture of rabbit kidney cells previously distributed by the firm, appeared to contain another type of cells (monkey kidney cells).
FDA Determined
Cause 2		 Process control
Action Diagnostic Hybrids issued a "Product Notification" letter dated January 23, 2009 in addition to verbal communication of the affected product beginning January 21, 2009. The firm requested that all affected product be discarded /destroyed and not use for diagnostic testing. Consignees were asked to complete and return a Fax-Back form. For further information, contact Diagnostic Hybrids Technical Services at 1-866-344-3477 or 1-740-589-3300.
Quantity in Commerce 1127 units
Distribution Worldwide Distribution -- United States (CA, FL, GA, MA, MO, NY, NJ, TN, TX and VA), Ontario Canada and Manitoba Canada.
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.
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