Recall Z-0483-2009 ยท LTD Paraquat Assay
Promega Corpopration
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 m
| Date | Dec 15, 2008 (initiated Jun 4, 2008) |
| Status | Terminated |
| Reason | 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 | 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 techserv@promega.com. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.