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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84518

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

Open FDA event record

Event summary

Timeline bucket
December 11, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Roche Diabetes Care, Inc.

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

3 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 3

Accu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose Monitoring System Catalog Number: 06908349001

Z-0997-2020
Recall number
Z-0997-2020
Initiated
December 11, 2019
Classification
Class II
Status
Terminated
Recalling firm
Roche Diabetes Care, Inc.
Quantity
82,332 vials

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Inability to dose the test strips, may result in a temporary inability to get a result that could lead to a delay in treatment and/or therapy decisions

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

Inability to dose the test strips, may result in a temporary inability to get a result that could lead to a delay in treatment and/or therapy decisions

Code information

Lot Number: 497864 NDC: 65702-0438-10 UPC: 3-65702-43810-1

Distribution pattern

Nationwide: Foreign: Austalia, India

device · product 2 of 3

Accu-Chek Aviva Plus Retail Strips 50 ct - intended for Blood Glucose Monitoring System Catalog Number: 06908217001

Z-0998-2020
Recall number
Z-0998-2020
Initiated
December 11, 2019
Classification
Class II
Status
Terminated
Recalling firm
Roche Diabetes Care, Inc.
Quantity
92,836 vials

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Inability to dose the test strips, may result in a temporary inability to get a result that could lead to a delay in treatment and/or therapy decisions

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

Inability to dose the test strips, may result in a temporary inability to get a result that could lead to a delay in treatment and/or therapy decisions

Code information

Lot Number:498315 NDC: 65702-0407-10 UPC: 3-65702-40710-7

Distribution pattern

Nationwide: Foreign: Austalia, India

device · product 3 of 3

ACCU-CHEK AVIVA ASPAC STRIP 50CT- intended for Blood Glucose Monitoring System Catalog Number: 06453970020

Z-0999-2020
Recall number
Z-0999-2020
Initiated
December 11, 2019
Classification
Class II
Status
Terminated
Recalling firm
Roche Diabetes Care, Inc.
Quantity
61,329 units (OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Inability to dose the test strips, may result in a temporary inability to get a result that could lead to a delay in treatment and/or therapy decisions

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

Inability to dose the test strips, may result in a temporary inability to get a result that could lead to a delay in treatment and/or therapy decisions

Code information

Lot Number: 498287

Distribution pattern

Nationwide: Foreign: Austalia, India