NeoMarkers Rabbit Monoclonal anti-Human Cyclin D1 Antibody (Clone SP4), immunochemistry Reagent and Kit, For In Vitro Di

FDA device recall Z-2424-2010 · posted 2010-09-15 · Terminated

Recall details

Recalling firm

Lab Vision Corporation

Reason for recall

Two lots may be contaminated with Ki-67 antibody, which could cause abnormal staining patterns, and produce false positive results.

Action taken

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

Status

Terminated

Product code

NJT

Quantity affected

103 units

Distribution

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,

Date initiated

2010-03-05

Date posted

2010-09-15

Date terminated

2011-03-21

Location

Fremont, CA