FDA Enforcement
Class III
Terminated
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.
Recall: Z-1676-2015
·
Reported June 3, 2015
Enforcement
- Recall Number
- Z-1676-2015
- Event ID
- 71229
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- Biocare Medical, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 3, 2015
- Initiation Date
- May 6, 2015
- Classification Date
- May 26, 2015
- Termination Date
- June 4, 2015
- Address
- 4040 Pike Ln, Concord, CA, 94520-1227, United States
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
Firm discovered that incorrect Instructions for Use were shipped with one lot of D2-40.
Code Info
Catalog number: PM266AA, lot 030615, Expiration: 2018/03.
Distribution
Worldwide Distribution - US Nationwide in the states of: MI, SC, NC, AZ, CA, MO, WI and Hungary, Spain and Austria.
Quantity
19 units