Exact FDA event identifier

Event 64310

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

Open FDA event record

Event summary

Timeline bucket: December 11, 2012
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 MAX PCR Cartridges Catalog #437519, box of 24 cartridges labeled in part:BD MAX PCR Cartridges, GeneOhm Sciences Canada, Inc. 2555 boul du Parc-Technologique, Quebec, Canada G1P 4S5BD Max Group B Streptococcus (GBS) Assay is an in vitro diagnostic (IVD) test for detection of GBS DNA in Lim Broth cultures. The BD MAX" PCR Cartridge is a consumable required for the BD MAX" System.

Z-0976-2013

Recall number: Z-0976-2013
Initiated: December 11, 2012
Classification: Class II
Status: Terminated
Recalling firm: Becton Dickinson & Co.
Quantity: 27 boxes/648 cartridges

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Cartridges are not sealing properly during PCR testing and may cause false results, indeterminates and/or invalid runs.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Cartridges are not sealing properly during PCR testing and may cause false results, indeterminates and/or invalid runs.

Code information

Lot/Exp. date: 2235001 2014-08-22

Distribution pattern

Worldwide Distribution - USA including CA, FL, IN, IL, KS, NY, OH, OR, PA, TX, and WI and the country of Belgium