Recall Z-0179-2015 ยท NJT Immunohistochemistry Reagents And Kits
Leica Microsystems, Inc.
Thyroglobulin (1D4) is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant, and supplied in Tris buffered saline with carrier protein, containing 0.35% ProClin 950 as a preservative. Total volume = 7 mL. This reagent is for in vitro diagnostic use. Thyroglobulin (1D4) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of t
| Date | Nov 6, 2014 (initiated Apr 18, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Unknown/Undetermined by firm |
| Action | 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 re |
| Quantity | 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, Internationally to Belgium, Bulgaria, France, Italy, Pakistan, Philippines, Russia, Saudi Arabia, Spain, T |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.