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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.

FDA Recall Z-1676-2015 · Posted 2015-05-26

Recalling FirmBiocare Medical, LLC
Recall StatusTerminated
Product CodeNJT
Date Initiated2015-05-06
Date Terminated2015-06-04
Product Quantity19 units

Reason for Recall

Firm discovered that incorrect Instructions for Use were shipped with one lot of D2-40.

Firm 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.

Root Cause

Labeling mix-ups

Distribution Pattern

Worldwide Distribution - US Nationwide in the states of: MI, SC, NC, AZ, CA, MO, WI and Hungary, Spain and Austria.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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