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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83513

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

Open FDA event record

Event summary

Timeline bucket
July 26, 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

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 Kiestra InoqulA Software Version 20.3.IVD automated specimen processing Catalog Number: 447202

Z-2438-2019
Recall number
Z-2438-2019
Initiated
July 26, 2019
Classification
Class II
Status
Terminated
Recalling firm
Becton Dickinson & Co.
Quantity
4 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
anomaly is present in InoqulA / InoqulA+ software

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

An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a mismatch between a specimen and plate

Code information

Catalog Number: 447202 Catalog Number/UDI INO-000287 00382904472023 INO-000286 00382904472023 INO-000269 00382904472023 INO-000281 00382904472023

Distribution pattern

Illinois, Iowa, Missouri, New York, Ohio, Tennessee World Wide (5): Singapore, Taiwan, France, Netherlands

device · product 2 of 2

BD Kiestra InoqulA+ Software Version 20.3. IVD automated specimen processing Catalog Number : 447213

Z-2439-2019
Recall number
Z-2439-2019
Initiated
July 26, 2019
Classification
Class II
Status
Terminated
Recalling firm
Becton Dickinson & Co.
Quantity
9 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
anomaly is present in InoqulA / InoqulA+ software

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

An anomaly is present in InoqulA / InoqulA+ software version 20.3, has the potential to cause a mismatch between a specimen and plate

Code information

Catalog Number: 447213 Serial Number/UDI: INO-000290 00382904472139 INO-000263 00382904472139 INO-000264 00382904472139 20130276 00382904472139 INO-000282 00382904472139 INO-000284 00382904472139 INO-000272 00382904472139 INO-000274 00382904472139

Distribution pattern

Illinois, Iowa, Missouri, New York, Ohio, Tennessee World Wide (5): Singapore, Taiwan, France, Netherlands