Richard-Allan Scientific Bio-Tite Specimen Containers. Product Usage: 10% NBF is used to store and fixate tissue prior t

FDA device recall Z-0015-2015 · posted 2014-10-09 · Terminated

Recall details

Recalling firm

Richard-Allan Scientific Company

Reason for recall

The affected lots could have NBF concentrations that are lower or higher than the desired specifications.

Action taken

The firm issued an "URGENT MEDICAL DEVICE RECALL" letter to all affected customers. The notification identified the affected products, reason for voluntary recall, risk to health, actions to be taken, and instructions to complete the attached Acknowledgement Form. For questions, contact Sarah Rickert at 269-544-5628 or sarah.rickert@thermofisher.com.

Root cause

Mixed-up of materials/components

Status

Terminated

Product code

LDY

Quantity affected

383 cases

Distribution

Worldwide Distribution-USA (nationwide) including the states of PA, IL, CA, TX, GA, WA, MA, KY, OH, NY, VA, NC, IN, NJ, MN, UT, HI, FL, KS, TN, MO, MI, MD, LA, NM, DE, CO, WV, OR, WI, AZ, SC, IA, and

Date initiated

2014-09-17

Date posted

2014-10-09

Date terminated

2016-10-27

Location

Kalamazoo, MI