Rabbit Kidney Culture, brand name: 'FreshCells'. The product is labeled as 'Rabbit Kidney' also known as 'Rbk' , 2-squar
FDA device recall Z-0822-2010 · posted 2010-02-24 · Terminated
Recall details
- Recalling firm
- Diagnostic Hybrids Inc
- 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).
- Action taken
- 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
- Status
- Terminated
- Product code
- KIR
- Quantity affected
- 1127 units
- Distribution
- Worldwide Distribution -- United States (CA, FL, GA, MA, MO, NY, NJ, TN, TX and VA), Ontario Canada and Manitoba Canada.
- Date initiated
- 2009-01-21
- Date posted
- 2010-02-24
- Date terminated
- 2010-09-21
- Location
- Athens, OH
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