Recall Z-2113-2014— Biogenex Laboratories, Inc.
Class II · Terminated
Class II FDA medical device recall by Biogenex Laboratories, Inc., initiated 2014-07-01, terminated 2014-07-24. FDA's recall record names no specific 510(k) clearance for this event. Product: InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use.. Reason: Product was distributed without 510(k) approval..
- Recalling firm
- Biogenex Laboratories, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-07-01
- Terminated
- 2014-07-24
- Firm location
- Fremont, CA, United States
Product description
InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use.
Reason for recall
Product was distributed without 510(k) approval.
Data sourced from openFDA. This site is unofficial and independent of the FDA.