Biocare Medical, LLC: Medical Device Recall in 2015 - (Recall #: Z-1535-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: March 17, 2015

Date Posted: May 6, 2015

Recall Number: Z-1535-2015

Event ID: 70823

Reason for Recall:

A drop in staining intensity over time has been observed. These lots may not meet their labeled shelf life.

Status: Terminated

Product Quantity: 44: 8 of lot 110912, 15 of lot 041913; 17 of lot 120310 and 4 of lot 110314

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.

Voluntary or Mandated:

Voluntary: Firm initiated