Exact FDA event identifier

Event 65619

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

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Event summary

Timeline bucket: June 13, 2013
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Becton Dickinson & Co.

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

BD Affirm VPIII Microbial Identification Tests, packaged in kits, 120 test\kit, Catalog # 446257 and 24 test\kit, Catalog # 446252; kits are labeled in part Becton, Dickinson and Company, 7 Loveton Circle Sparks, MD 21152 USA, 800-638-8663, www.bd.com/ds The Affirm VPIII Microbial Identification Test is a DNA probe test intended for use in the detection and identification of Candida species,

Z-1812-2013

Recall number: Z-1812-2013
Initiated: June 13, 2013
Classification: Class II
Status: Terminated
Recalling firm: Becton Dickinson & Co.
Quantity: 177 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

In vitro diagnostic test kit may exhibit invalid internal negative control results.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

In vitro diagnostic test kit may exhibit invalid internal negative control results.

Code information

Cat #446257: Lot 3035126 Exp 12/04/13 Cat #446252: Lot 3065261 Exp 08/31/13

Distribution pattern

Nationwide Distribution