Z-0483-2009

RNAgents Total RNA Isolation System (Cat. # Z5110). Kit Box label/Box drawer label. For Laboratory Use...

Name: Z-0483-2009 RNAgents Total RNA Isolation System (Cat. # Z5110). Kit Box label/Box drawer label. For Laboratory Use...
Creator: Promega Corpopration
Published: 2008-06-04
License: https://open.fda.gov/license/

Promega Corporation / initiated 2008-06-04 / Terminated / root cause: packaging

FDA source

Promega Corpopration began a recall of RNAgents Total RNA Isolation System (Cat. # Z5110). Kit Box label/Box drawer label. For Laboratory Use. Promega Corporation, Madison, WI. USA. Bottle Label... on 2008-06-04. The reason FDA records is "Promega Corporation received reports of leaking bottles of Phenol:Chloroform:Isoamyl Alcohol (Part # Z5112), a component of the RNAgents Total RNA Isolation System (Catalog # Z5110). Promega product Z5112 is a mixture...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0483-2009
Status: Terminated
Initiated: 2008-06-04
Posted: 2008-12-15
Terminated: 2012-06-26
Recalling firm: Promega Corporation
Product: RNAgents Total RNA Isolation System (Cat. # Z5110). Kit Box label/Box drawer label. For Laboratory Use. Promega Corporation, Madison, WI. USA. Bottle Label: Phenol: Chloroform: Isoamyl Alcohol (Cat.# Z5112). Part Two of Two of Z5110. Size 100ml. For laboratory Use. A component of the RNAgents Total RNA Isolation System. The RNAgents Total RNA Isolation System provides a scalable method for RNA isolation from 6 grams of tissue or 6 x 10 (eighth power) cultured cells. The system reduces the level of chromosomal DNA, a major advantage when the downstream application of amplification and analysis of RNA transcripts is desired. Isolated RNA can be resuspended in any volume, making the system ideal for microarrays.
Product code: LTD Paraquat Assay
Reason for recall: Promega Corporation received reports of leaking bottles of Phenol:Chloroform:Isoamyl Alcohol (Part # Z5112), a component of the RNAgents Total RNA Isolation System (Catalog # Z5110). Promega product Z5112 is a mixture of phenol, chloroform and isoamyl alcohol. If phenol contacts skin, it can cause burns and poisoning. The fumes of this product are also harmful.
Root cause tag: packaging
FDA root cause: Packaging
Action: Consignees were sent a "Promega Urgent Product Alert-Risk of Injury" letter dated June 9, 2008. The letter described the product, problem and provided instructions on handling, inspection and disposition of product. In addition, E-mail notifications were sent to distributors and branch offices on May 29,2008. For questions and additional information, contact your local Promega representative or Promega Technical Service at 800-356-9526 and press "4", or e-mail at [email protected].
Quantity in commerce: 836
Distribution: Worldwide Distribution: USA including states of IN, ME, NE, NY, WI, PA, NC, FL, OR, UT, MI, IL, AL, OR, GA, CA, MD, TX, MA, UT, MO, OH, and LA, and countries of Canada, Mexico, Brasil, China, Japan, Germany, Singapore, Great Britain, Australia and France.
Product codes and lots: Lot Codes: 237809 and 248195.

Product code LTD

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)