Reported Jul 30, 2014 · Terminated
InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use.
Biogenex Laboratories, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Biogenex Laboratories, Inc. · 49026 Milmont Dr · Fremont, CA · 94538-7301
Is this the product you have?
- InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use.
- Lot codes and dates
- Catalog number RD471-60KLot
- numbers
RD4710111Exp Jan 2012RD4710411Exp. Apr 2012RD4711013Exp Oct 2014
- Amount recalled
- 4 kits
Why it was recalled
Product was distributed without 510(k) approval.
This product could cause temporary or reversible health problems — stop using it.
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