Recall Z-1676-2015 ยท NJT Immunohistochemistry Reagents And Kits
Biocare Medical, LLC
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.
| Date | May 26, 2015 (initiated May 6, 2015) |
| Status | Terminated |
| Reason | Firm discovered that incorrect Instructions for Use were shipped with one lot of D2-40. |
| Root cause | Labeling mix-ups |
| Action | Biocare Medical sent a Medical Device Notification letter dated May 6, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete all actions listed on the enclosed Return Response Form. |
| Quantity | 19 units |
| Distribution | Worldwide Distribution - US Nationwide in the states of: MI, SC, NC, AZ, CA, MO, WI and Hungary, Spain and Austria. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.