Z-0822-2010

Rabbit Kidney Culture, brand name: 'FreshCells'. The product is labeled as 'Rabbit Kidney' also known as...

Name: Z-0822-2010 Rabbit Kidney Culture, brand name: 'FreshCells'. The product is labeled as 'Rabbit Kidney' also known as...
Creator: Diagnostic Hybrids Inc
Published: 2009-01-21
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2009-01-21 / Terminated / root cause: manufacturing process

FDA source

Diagnostic Hybrids Inc began a recall of 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... on 2009-01-21. The reason FDA records is "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)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0822-2010
Status: Terminated
Initiated: 2009-01-21
Posted: 2010-02-24
Terminated: 2010-09-21
Recalling firm: Ortho-Clinical Diagnostics, Inc.
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.
Product code: KIR Cells, Animal And Human, Cultured
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).
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: Catalog Number: 48-0600, Lot #480109.

Product code KIR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)