Device 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.
Z-1676-2015
Product summary
- Event
- Event 71229
- Status
- Terminated
- Classification
- Class III
- Quantity
- 19 units
- Official record key
device-enforcement:Z-1676-2015
Official wording
Reason: Firm discovered that incorrect Instructions for Use were shipped with one lot of D2-40.
Code information: Catalog number: PM266AA, lot 030615, Expiration: 2018/03.
Distribution pattern: Worldwide Distribution - US Nationwide in the states of: MI, SC, NC, AZ, CA, MO, WI and Hungary, Spain and Austria.
Derived failure modes
-
Unknown
Firm discovered that incorrect Instructions for Use were shipped with one lot of D2-40.