Z-1535-2015Class II

CD99 Catalog number PM008 AA; For In Vitro Diagnostic Use

Name: Z-1535-2015 CD99 Catalog number PM008 AA; For In Vitro Diagnostic Use
Creator: Biocare Medical, LLC
Published: 2015-03-17
License: https://open.fda.gov/license/

Biocare Medical LLC / initiated 2015-03-17 / Terminated / root cause: labeling and UDI

FDA source

Biocare Medical, LLC began a recall of CD99 Catalog number PM008 AA; For In Vitro Diagnostic Use. Product Usage: Provides adjunctive diagnostic information following the primary diagnosis of a... on 2015-03-17. FDA classified it as Class II and gives the reason as "A drop in staining intensity over time has been observed. These lots may not meet their labeled shelf life". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1535-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-17
Posted: 2015-04-27
Terminated: 2015-06-15
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.
Product code: NJT Immunohistochemistry Reagents And Kits
Reason for recall: A drop in staining intensity over time has been observed. These lots may not meet their labeled shelf life.
Root cause tag: labeling and UDI
FDA 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 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.
Product codes and lots: Catalog number PM008 AA; Lot numbers: 110912, Exp 2015/11; 041913, Expiry 2016/04; 120313, Expiry 2016/12; 110314, Expiry 2017/11.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1535-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1535-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-06	2015-04-27

Product code NJT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)