Z-1535-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 6, 2015
- Initiation Date
- March 17, 2015
- Termination Date
- June 15, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 44: 8 of lot 110912, 15 of lot 041913; 17 of lot 120310 and 4 of lot 110314
Product Description
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.
Reason for Recall
A drop in staining intensity over time has been observed. These lots may not meet their labeled shelf life.
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.
Code Information
Catalog number PM008 AA; Lot numbers: 110912, Exp 2015/11; 041913, Expiry 2016/04; 120313, Expiry 2016/12; 110314, Expiry 2017/11.