Exact FDA event identifier

Event 89898

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

Open FDA event record

Event summary

Timeline bucket: March 09, 2022
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

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

RocheDiabetes Care Platform Software version 2.5.2 material number 08888353001. This is a web application software hosted on a server. There is no physical product.

Z-1008-2022

Recall number: Z-1008-2022
Initiated: March 09, 2022
Classification: Class II
Status: Terminated
Recalling firm: Roche Diabetes Care, Inc.
Quantity: 81 registered accounts

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Potential for patient data mismatch when using browser "back" button to navigate between patients when using the diabetes management 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

Potential for patient data mismatch when using browser "back" button to navigate between patients when using the diabetes management software.

Code information

Date of manufacture: 2021-11

Distribution pattern

US Nationwide Distribution: AK, AZ, CA, CO, DC, FL, GA, IL, IN, MN, NC, NJ, NY, PA, RI, SC, TX, WI