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U.S. Department of Health and Human Services

Class 2 Device Recall CD99

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  Class 2 Device Recall CD99 see related information
Date Initiated by Firm March 17, 2015
Date Posted April 27, 2015
Recall Status1 Terminated 3 on June 15, 2015
Recall Number Z-1535-2015
Recall Event ID 70823
Product Classification Immunohistochemistry reagents and kits - Product Code NJT
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.
Code Information Catalog number PM008 AA; Lot numbers: 110912, Exp 2015/11; 041913, Expiry 2016/04; 120313, Expiry 2016/12; 110314, Expiry 2017/11.
Recalling Firm/
Manufacturer		 Biocare Medical, LLC
4040 Pike Ln
Concord CA 94520-1227
For Additional Information Contact Scott Huntsman
925-603-8033
Manufacturer Reason
for Recall		 A drop in staining intensity over time has been observed. These lots may not meet their labeled shelf life.
FDA Determined
Cause 2		 Unknown/Undetermined by 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.
Quantity in Commerce 44: 8 of lot 110912, 15 of lot 041913; 17 of lot 120310 and 4 of lot 110314
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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