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.
FDA Recall Z-1535-2015 · Posted 2015-04-27
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Recalling FirmBiocare Medical, LLC
Recall StatusTerminated
Product CodeNJT
Date Initiated2015-03-17
Date Terminated2015-06-15
Product Quantity44: 8 of lot 110912, 15 of lot 041913; 17 of lot 120310 and 4 of lot 110314
Reason for Recall
A drop in staining intensity over time has been observed. These lots may not meet their labeled shelf life.
Firm Action
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.
Root Cause
Unknown/Undetermined by firm
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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