Recall Z-1535-2015— Biocare Medical, LLC
Class II · Terminated
Class II FDA medical device recall by Biocare Medical, LLC, initiated 2015-03-17, terminated 2015-06-15. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Biocare Medical, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-03-17
- Terminated
- 2015-06-15
- Firm location
- Concord, CA, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.