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U.S. Department of Health and Human Services

Class 2 Device Recall Phenol: Chloroform:Isoamyl Alcohol

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 Class 2 Device Recall Phenol: Chloroform:Isoamyl Alcoholsee related information
Date Initiated by FirmJune 04, 2008
Date PostedDecember 15, 2008
Recall Status1 Terminated 3 on June 26, 2012
Recall NumberZ-0483-2009
Recall Event ID 49586
Product Classification General Purpose Reagent - Product Code LTD
ProductRNAgents 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.
Code Information Lot Codes: 237809 and 248195.
FEI Number 3002622561
Recalling Firm/
Manufacturer		 Promega Corpopration
2800 Woods Hollow Rd
Madison WI 53711-5300
For Additional Information Contact
608-277-2634
Manufacturer 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.
FDA Determined
Cause 2		Packaging
ActionConsignees 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 in Commerce836
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
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