Device 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.
Z-1535-2015
Product summary
- Event
- Event 70823
- Status
- Terminated
- Classification
- Class II
- Quantity
- 44: 8 of lot 110912, 15 of lot 041913; 17 of lot 120310 and 4 of lot 110314
- Official record key
device-enforcement:Z-1535-2015
Official wording
Reason: A drop in staining intensity over time has been observed. These lots may not meet their labeled shelf life.
Code information: Catalog number PM008 AA; Lot numbers: 110912, Exp 2015/11; 041913, Expiry 2016/04; 120313, Expiry 2016/12; 110314, Expiry 2017/11.
Distribution pattern: 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.
Derived failure modes
-
Unknown
A drop in staining intensity over time has been observed. These lots may not meet their labeled shelf life.