ThermoGenesis Corporation Recalls AutoXpress Units Used To Process and Preserve Stem Cells and Umbilical Cord Blood
- Company failed to perform
quality-control procedures required by the federal government.
- Recall
affects approximately 7000 units sold in the U.S. from
late 2006 until December 2007.
- FDA states that contaminated
cord blood samples could pose a “significant adverse
health outcome” such as infection or fever, if used
in the future to treat disease.
On this Page:
Stem Cell Processing and Cord Blood Samples
ThermoGenesis Corp. of Rancho Cordova,
CA, is a leading producer of equipment used to process and preserve
stem cells. Stem cells from umbilical cord blood can be used
to treat a number of diseases, and researchers expect to develop
many more uses in the future. But the failure
of ThermoGenesis to conduct an important required test, could result in the storage
of contaminated cord blood samples that may injure future patients.
After
processing, the cells are stored at cell banks, such as the Cord
Blood Registry, in San Bruno, CA. The Registry has an initial
charge of $2,000 plus an annual storage fee of $125, to process,
freeze and archive a baby’s cord blood, often
using the ThermoGenesis AutoXpress System to process the cord
blood. It has collected over 200,000 samples, to date.
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AutoXpress AXP
System 8-5101 Bag Sets May Be Contaminated
ThermoGenesis distributed some lots
of AXP Bag Sets 8-5101 without being tested for endotoxin (pyrogen)
contamination. The test specifically checks for the presence
of Limulus Amebocyte Lysate (LAL). According to the FDA, ThermoGenesis
cannot guarantee that the untested lots are free of contamination.
For a list of recalled lot numbers and
expiration dates of the AXP 8-5101, go to the FDA
Web site.
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Testing for Contamination of Frozen Units
Currently, there is no testing available
for cord blood units that have already been processed and frozen
with AXP 8-5101 bag sets from the affected lots. The FDA
states that ThermoGenesis is trying to develop a post-thaw endotoxin
contamination procedure.
However, as of the date of the FDA announcement
on February 19, 2008, no approved post-thaw test had been developed.
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FDA Urges Caution in Use of Cord Blood
from
Recalled
Lots
The FDA recall announcement of February
19, 2008, warns consumers that if contaminated
cord blood is
used in the future, “there could be a significant adverse
health outcome (e.g. fever, sepsis) which would necessitate medical
intervention,” although the probability of contamination
in significant amounts is “low.”
- The FDA recommends
that consumers avoid using cord blood products processed with
AXP 8-5101 bag sets from recalled lots, unless there is no other
alternative.
- All such affected cord blood units should
be “tagged” as
possibly contaminated.
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Contact Us
If you are a consumer who relied upon
ThermoGenesis Corporation to provide contamination-free cord
blood and stem cell processing and storage, contact the attorneys
of Kershaw, Cutter and Ratinoff.
The attorneys of Kershaw, Cutter & Ratinoff
have handled hundreds of cases involving unfair or deceptive
business practices. In recent years, KCR has litigated and settled
numerous nationwide cases involving unfair or deceptive business
practices such as:
- Ford Motor Company’s misrepresenting
the rollover risks of Ford Explorers
- Allstate overcharging
for auto insurance policy premiums
- Home builders misrepresenting
the actual square footage of tract homes
- Employers unreasonably
refusing to pay overtime wages
We have the specific knowledge
and experience to help our clients obtain fair compensation
in these complex cases.
If you paid for the harvesting, processing,
and storage of cord blood, you have the right to expect that
these blood products will be processed under the highest standards
of sterility, and will not be rendered both useless and dangerous
because of insufficient testing. You also have the right to know
if your specific cord blood unit has been contaminated. You may
be entitled to reimbursement of the money you have already spent,
as well as payment of other damages related to the mishandling
of cord blood.
Please click
here for a free case evaluation.
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Nationally recognized civil litigation attorneys
If
you are looking for attorneys with a proven record of success,
please call us toll-free at 888-285-3333 for
a free case evaluation. To find out more about our excellent
team of lawyers, visit our attorney
profiles.
Copyright © 2008 Kershaw, Cutter & Ratinoff LLP.
All Rights Reserved.
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ThermoGenesis recalling 7,000 Auto-Xpress units used in stem
cell work
The Sacramento Bee — February
23, 2008
FDA Web site: ThermoGenesis Recall
Date Recall
Initiated: February 19, 2008
For
a list of recalled
lot numbers and
expiration dates of
the
AXP 8-5101,
go to the FDA
Web site.
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