Reported Jun 3, 2015 · Terminated

D2-40 (Lymphatic Marker); For In Vitro Diagnostic; Catalog number: PM266AA Product Usage: In Vitro Diagnostic Use.: a…

Biocare Medical, LLC

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Biocare Medical, LLC · 4040 Pike Ln · Concord, CA · 94520-1227

Is this the product you have?

  • D2-40 (Lymphatic Marker); For In Vitro Diagnostic
  • Catalog numberPM266AA
  • Product UsageIn 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
Lot codes and dates
  • Catalog number
    • PM266AA
    • lot 030615
  • Expiration2018/03
Amount recalled
19 units

Where it was sold

Why it was recalled

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

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 4, 2015 · Data as of Sep 19, 6:07 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.