Recall Z-1535-2015 ยท NJT Immunohistochemistry Reagents And Kits
Biocare Medical, LLC
CD99 Catalog number PM008 AA; For In Vitro Diagnostic Use. Product Usage: Provides adjunctive diagnostic information following the primary diagnosis of a neoplasm by conventional histopathology methods.
| Date | Apr 27, 2015 (initiated Mar 17, 2015) |
| Status | Terminated |
| Reason | A drop in staining intensity over time has been observed. These lots may not meet their labeled shelf life. |
| Root cause | Unknown/Undetermined by firm |
| Action | Biocare sent a Medical Device Notification letters dated March 17, 2015 to all affected sites. The letters identify the affected product, problem, actions to be taken and the fact that it affects all identified lots shipped between 02/13/13 and / 01/28/15. The letters instructed customers to immediately discontinue further use of the recalled lots, dispose of them according to state and local regulations and complete the response form and returned by April 7, 2015. Credit will be issued upon receipt of the response form. |
| Quantity | 44: 8 of lot 110912, 15 of lot 041913; 17 of lot 120310 and 4 of lot 110314 |
| Distribution | Worldwide Distribution - US nationwide in the states of TX, KS, OK, NJ, LA, GA, NC, SC, VA, and the countries of Spain, Austria, Ecuador, Dominican Republic, Vietnam, Kuwait, Hungary and Israel. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.