HER2 Image Analysis Manual Read of HER2 Digital Slides ER/PR Image Analysis IHC PR Breast Tissue Manual Read of Digital

FDA device recall Z-1152-2014 · posted 2014-03-07 · Terminated

Recall details

Recalling firm

Leica Biosystems Imaging, Inc.

Reason for recall

In an abundance of caution, Aperio (now known as Lecia Biosystems) is providing additional information to clarify that the use of Digital IHC Breast/ER/Dako Image Analysis, Digital IHC Breast/HER2 Digital Read, Digital IHC Breast/HER2/Dako Image Analysis, Digital IHC Breast/PR Digital Read and Digital IHC Breast/PR/Dako Image Analysis with the RUO products identified in that earlier notification i

Action taken

Aperio (now known as Leica Biosystems) sent an recall notification letter on February 7, 2014, via USPS mail. The letter dated January 31, 2014, informed customers of the reason for the notification, product description, provided additional information to clarify that the use of Digital IHC Breast/ER/Dako Image Analysis, Digital IHC Breast/HER2 Digital Read, Digital IHC Breast/HER2/Dako Image Analysis, Digital IHC Breast/PR Digital Read and Digital IHC Breast/PR/Dako Image Analysis with the RUO products identified in that earlier notification is also for Research Use Only and not for use in diagnostic procedures. The notice also included updated manuals for the image analysis algorthithms so that the intended use in the hardware and software manuals is consistent. An acknowledgement form and contact information was also provided. We sincerely apologize for any inconvenience this may have caused. If you have any questions, please do not hesitate to contact Aperio Technical Support at (866) 478-3999.

Root cause

Labeling False and Misleading

Status

Terminated

Product code

NOT

Quantity affected

78

Distribution

US Distribution including the states of FL, WA, PA, MS, TX, MN CA, NY, NJ, NC, CO and OH.

Date initiated

2014-02-07

Date posted

2014-03-07

Date terminated

2014-04-15

Location

Vista, CA