Recall Z-1676-2015— Biocare Medical, LLC
Class III · Terminated
Class III FDA medical device recall by Biocare Medical, LLC, initiated 2015-05-06, terminated 2015-06-04. FDA's recall record names no specific 510(k) clearance for this event. Product: D2-40 (Lymphatic Marker); For In Vitro Diagnostic; Catalog number: PM266AA Product Usage: In Vitro Diagnostic Use.: a mouse monoclonal antibody that is intended for laboratory use in the qualitative identification of O-linked sialoglyprotein protein by immunohistochemistry (ICH) in formalin fixed paraffin embedded human tissues.. Reason: Firm discovered that incorrect Instructions for Use were shipped with one lot of D2-40..
- Recalling firm
- Biocare Medical, LLC
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2015-05-06
- Terminated
- 2015-06-04
- Firm location
- Concord, CA, United States
Product description
D2-40 (Lymphatic Marker); For In Vitro Diagnostic; Catalog number: PM266AA Product Usage: In Vitro Diagnostic Use.: a mouse monoclonal antibody that is intended for laboratory use in the qualitative identification of O-linked sialoglyprotein protein by immunohistochemistry (ICH) in formalin fixed paraffin embedded human tissues.
Reason for recall
Firm discovered that incorrect Instructions for Use were shipped with one lot of D2-40.
Data sourced from openFDA. This site is unofficial and independent of the FDA.