Thyroglobulin (1D4) is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant, and supplied in

FDA device recall Z-0179-2015 · posted 2014-11-06 · Terminated

Recall details

Recalling firm

Leica Microsystems, Inc.

Reason for recall

Bond Ready to Use Primary Antibody Thyroglobulin does not function as intended up to the expiry date on the product labelling. This was detected through an on-going stability program. There is a link between the age of the product and staining intensity.

Action taken

Leica Biosystems sent a Medical Device Recall Notification letter dated April 18, 2014, to all affected customers. The letter included instructions for customers to: 1) assess any results previously obtained by using the recalled products; 2) identify and destroy any unused or partly used recalled products or confirm that the recalled products are no longer in stock; and, 3) complete and return the attached Medical Device Recall Notification Acknowledgement Form. Customers with questions were instructed to contact Leica Microsystems by e-mail at LMGRA@leica-microsystems.com. For questions regarding this recall call 847-405-5413.

Root cause

Unknown/Undetermined by firm

Status

Terminated

Product code

NJT

Quantity affected

180 units

Distribution

Worldwide Distribution - USA including AR, AZ, CA, CO, CT, FL, GA, IL, KY, LA, MA, MD, MI, MN, MO, MT, MY, NC, NH, NJ, NY, OH, ON, OR, PA, TN, TX, UT, VA, WA, WI and the District of Columbia, Internat

Date initiated

2014-04-18

Date posted

2014-11-06

Date terminated

2017-08-14

Location

Buffalo Grove, IL