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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79769

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 02, 2018
Product types
Device
Classifications
Class III
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

2 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 2

BD MAX DNA MMK (SPC) For Laboratory Use, catalog no. 442829

Z-1544-2018
Recall number
Z-1544-2018
Initiated
March 02, 2018
Classification
Class III
Status
Terminated
Recalling firm
Becton Dickinson & Co.
Quantity
13,898

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The package insert incorrectly lists the volume of the primer and probe diluent to use for the reconstitution of the master mix tube. Adding the incorrect amount of diluent could have an effect on the assay.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The package insert incorrectly lists the volume of the primer and probe diluent to use for the reconstitution of the master mix tube. Adding the incorrect amount of diluent could have an effect on the assay.

Code information

All since 08/20/2014

Distribution pattern

Distributed to accounts in 8 states: CA, FL, NJ, NY, OR, PA, VA, and WI. International distribution to Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Europe, Hong Kong, Japan, Singapore, Taiwan, and Thailand.

device · product 2 of 2

BD MAX DNA MMK Lab Use, catalog no. 442828

Z-1545-2018
Recall number
Z-1545-2018
Initiated
March 02, 2018
Classification
Class III
Status
Terminated
Recalling firm
Becton Dickinson & Co.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The package insert incorrectly lists the volume of the primer and probe diluent to use for the reconstitution of the master mix tube. Adding the incorrect amount of diluent could have an effect on the assay.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The package insert incorrectly lists the volume of the primer and probe diluent to use for the reconstitution of the master mix tube. Adding the incorrect amount of diluent could have an effect on the assay.

Code information

All since 08/20/2014

Distribution pattern

Distributed to accounts in 8 states: CA, FL, NJ, NY, OR, PA, VA, and WI. International distribution to Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Europe, Hong Kong, Japan, Singapore, Taiwan, and Thailand.