Exact FDA event identifier

Event 82225

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

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Event summary

Timeline bucket: February 21, 2019
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 Synapsys Laboratory Solutions Catalog Number:444150 Product Usage: BD Synapsys is a laboratory software solution providing data management and workflow management functionality across clinical diagnostic activities. The software integrates operational and clinical data points from laboratory hardware, with patient data received from external software systems allowing for the aggregation, evaluation, dissemination of knowledge using all data, anywhere, anytime. Currently Release 2 of BD Synapsys can connect to both Lab Automation (Kiestra) and BACTEC instruments.

Z-1051-2019

Recall number: Z-1051-2019
Initiated: February 21, 2019
Classification: Class II
Status: Terminated
Recalling firm: Becton Dickinson & Co.
Quantity: 5 sites

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

BD Synapsys version 2.1 allowed the potential for a test order to be associated to an incorrect culture record.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

BD Synapsys version 2.1 allowed the potential for a test order to be associated to an incorrect culture record.

Code information

BD Synapsys version 2.1 UDI: 00382904441500

Distribution pattern

Worldwide Distribution - US: Nationwide in the states of OH, IL, MO, TN and the countries of Netherlands