Recall Z-1535-2015
Biocare Medical, LLC · initiated March 17, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Catalog number PM008 AA; Lot numbers: 110912, Exp 2015/11; 041913, Expiry 2016/04; 120313, Expiry 2016/12; 110314, Expiry 2017/11.
Reason for recall
A drop in staining intensity over time has been observed. These lots may not meet their labeled shelf life.
FDA-determined cause: Unknown/Undetermined by firm
Action taken
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.
Details
- Recall number
- Z-1535-2015
- Initiated
- March 17, 2015
- Posted by FDA
- April 27, 2015
- Terminated
- June 15, 2015
- Product code
- NJT – Immunohistochemistry Reagents And Kits
- 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.
- Recalling firm
- Biocare Medical, LLC, Concord, CA