NeoMarkers Rabbit Monoclonal anti-Human Cyclin D1 Antibody (Clone SP4), immunochemistry Reagent and Kit, For In Vitro Diagnostic use, manufactured by Lab Vision Products, Fremont, CA, a subsidiary of ThermoFisher Scientific
FDA Recall Z-2424-2010 · Posted 2010-09-15
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Recalling FirmLab Vision Corporation
Recall StatusTerminated
Product CodeNJT
Date Initiated2010-03-05
Date Terminated2011-03-21
Product Quantity103 units
Reason for Recall
Two lots may be contaminated with Ki-67 antibody, which could cause abnormal staining patterns, and produce false positive results.
Firm Action
Thermo Fisher Scientific issued an "Advisory Notice" letter dated March 5, 2010 to all domestic customers and international distributors. The letter described the product, problem and action to be taken.
Customers were instructed to:
1) discard the affected lots, and
2) retest specimens using a replacement lot supplied by the firm, and
3) complete and return the Confirmation of Receipt Form via fax to 1-510-979-5489
International distributors were instructed to:
1) place the affected lots and replace with a replacement lot supplied by the firm, and
2) provide customers with copies of the customer letter, and
3) complete and return the Confirmation of Receipt Form via fax to 1-510-979-5489
For questions, contact Thermo Fisher Scientific at 1-800-828-1628 or 1-510-771-1595.
Root Cause
Material/Component Contamination
Distribution Pattern
Worldwide Distribution: USA, including the states of CA, SC, IL NY, WI, PA, MN, AL, WA, MA, and KS, and the coutnries of Austria, Australia, Denmark, Finland, France, Germany, Hong Kong, Italy, Japan, Malaysia, the Netherlands, Norway, Pakistan, Poland, Portugal, Russia, the UK, and Turkey.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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