Estrogen Receptor AB-11 (Clone ID5) Mouse Monoclonal Antibody 1 mk (2mg.ml) Manufactured by: Lab Vision Corporation, Fre

FDA device recall Z-0775-2014 · posted 2014-01-16 · Terminated

Recall details

Recalling firm

Lab Vision Corporation

Reason for recall

Reports that the product is not performing as expected. In house testing showed no staining on breast cancer tissues.

Action taken

Lab Vision Corporation part of Thermo Fisher Scientific sent an Urgent Medical Device Recall letter dated December 6, 2013, to all affected customers. Revised letters will be sent on January 8, 2014. Changes include that the reagent is an Analyte Specific Reagent (ASR) and not an in vitro diagnostic device in the US. They also clarify that a false positive was reported by a customer and a false negative was confirmed during in house testing. Letters also correct the expiry date from 12/2013 to 03/2015. Data sheet was also updated to eliminate information stating that the presence of ER in breast tumors indicates an increased likelihood of response to estrogen therapy and also that the positive control must be determined by the investigator. If you have any questions, please contact Technical Service at 1-800-522-7270, option 2, option 7.

Root cause

Under Investigation by firm

Status

Terminated

Product code

MVU

Quantity affected

5

Distribution

Worldwide Distribution: US (nationwide) including the states of TX and MA and internationally to: Turkey.

Date initiated

2013-12-06

Date posted

2014-01-16

Date terminated

2014-02-25

Location

Fremont, CA