Z-1535-2015 Class II Terminated
FDA device recall Z-1535-2015 was initiated by Biocare Medical, LLC on March 17, 2015 and is designated Class II. Reason for recall: A drop in staining intensity over time has been observed. These lots may not meet their labeled shelf life. The recall status is terminated (terminated June 15, 2015). Affected quantity: 44: 8 of lot 110912, 15 of lot 041913; 17 of lot 120310 and 4 of lot 110314.
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.