CD99 Catalog number PM008 AA — Class II medical device recall Z-1535-2015
Terminated recall by Biocare Medical, LLC, reported 2015-05-06, distributed nationwide. A drop in staining intensity over time has been observed. These lots may not meet their labeled shelf life.
| Recall number | Z-1535-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biocare Medical, LLC, Concord, CA, United States |
| Recall initiated | 2015-03-17 |
| Classified | 2015-04-27 |
| Reported by FDA | 2015-05-06 |
| Terminated | 2015-06-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, DO, EC, ES, HU, IL, KW, VN |
| Reason classes | labeling |
| Lot numbers | 041913, 110314, 110912, 120313, 2015/11, 2016/04, 2016/12, 2017/11 |
| Model numbers | PM008AA |
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.
Reason for recall
A drop in staining intensity over time has been observed. These lots may not meet their labeled shelf life.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1535-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.