Lab Vision Corporation recalls Thermo Scientific p21 WF1 Ab-3 (DCS-60.2) 1 ml (0.4mg/ml): Product code: MS-230-P and MS-230P0; Hematology: p21WAF1/Cip…

Recall date

October 27, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0322-2016

FDA classification

Class III

Brand / firm

Lab Vision Corporation

Sold / distributed

Worldwide Distribution: US distribution to states of: CA and WA, and countries of: Serbia, Germany and Netherlands.

Why it was recalled

It was discovered that the labeling of MS-230 antibody incorrectly describes the concentration - label reads 0.2mg/ml but it is actually 0.4 mg/ml.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Thermo Scientific p21 WF1 Ab-3 (DCS-60.2) 1 ml (0.4mg/ml): Product code: MS-230-P and MS-230P0; Hematology: p21WAF1/Cip1/Sdi1/Pic1 is a tumor suppressor protein. Expression of p21WAF1 is induced by wild type, but not mutant, p53 suppressor protein. The p21WAF1 protein binds to cyclin/CDK complexes and inhibits their kinase activity thereby stopping cell cycle progression. It also binds to PCNA (proliferating cell nuclear antigen) and blocks DNA replication but not the DNA repair process. Product is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin-embedded tissue sections, to be viewed by light microscopy.