FDA Medical Device Recalls (openFDA)
Biocare Medical, LLC: 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.
- Recall number
- Z-1535-2015
- Recalling firm
- Biocare Medical, LLC
- 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.
- Status
- Terminated
- Initiated
- 2015-03-17
- Posted
- 2015-04-27
- Terminated
- 2015-06-15
- Reason
- A drop in staining intensity over time has been observed. These lots may not meet their labeled shelf life.
- Root cause
- 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
- 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.
- Lot, serial or model codes
- Catalog number PM008 AA; Lot numbers: 110912, Exp 2015/11; 041913, Expiry 2016/04; 120313, Expiry 2016/12; 110314, Expiry 2017/11.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NJT
- Firm FEI
- 3004140393
- Firm city
- Concord
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28