Reported Dec 2, 2015 · Terminated

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

Lab Vision Corporation

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

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: Lab Vision Corporation · 46117 Landing Pkwy · Fremont, CA · 94538-6407

Thermo Scientific p21 WF1 Ab-3 (DCS-60.2) 1 ml (0.4mg/ml):
Product codeMS-230-P and MS-230P0
Hematologyp21WAF1/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

Lot codes and dates: Product code
MS-230-P
lot 230P1409A
Expiry 9-2016
Product code
MS-230-P0
lot 230P1409C
Expiry 9-2016
Amount recalled: 5 vials

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.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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