FDA Device recall Z-1535-2015
CD99 Catalog number PM008 AA
- FDA Device
- Class II
- terminated
- Published 2015-05-06
On 2015-05-06 the FDA classified a Class II recall of CD99 Catalog number PM008 AA by Biocare Medical, citing A drop in staining intensity over time has been observed. These lots may not meet their labeled shelf life.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1535-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-17 |
| Published | 2015-05-06 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biocare Medical |
| Distribution | US |
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
A drop in staining intensity over time has been observed. These lots may not meet their labeled shelf life.
Identifiers
| code_info | Catalog number PM008 AA; Lot numbers: 110912, Exp 2015/11; 041913, Expiry 2016/04; 120313, Expiry 2016/12; 110314, Expiry 2017/11. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1535-2015%22
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