Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71229

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 06, 2015
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Biocare Medical, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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
Recall number
Z-1676-2015
Initiated
May 06, 2015
Classification
Class III
Status
Terminated
Recalling firm
Biocare Medical, LLC
Quantity
19 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm discovered that incorrect Instructions for Use were shipped with one lot of D2-40.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.