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.
FDA Recall Z-0822-2010 · Posted 2010-02-24
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Recalling FirmDiagnostic Hybrids Inc
Recall StatusTerminated
Product CodeKIR
Date Initiated2009-01-21
Date Terminated2010-09-21
Product Quantity1127 units
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).
Firm 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.
Root Cause
Process control
Distribution Pattern
Worldwide Distribution -- United States (CA, FL, GA, MA, MO, NY, NJ, TN, TX and VA), Ontario Canada and Manitoba Canada.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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