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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81187

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

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Event summary

Timeline bucket
October 05, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Tosoh Bioscience 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

AIA-900 Analyzer, Product code 022930, 022930R

Z-0469-2019
Recall number
Z-0469-2019
Initiated
October 05, 2018
Classification
Class II
Status
Terminated
Recalling firm
Tosoh Bioscience Inc
Quantity
393

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Tosoh Bioscience has become aware of a potential issue with the pickup arm and pickup arm motor on the AIA-900 Analyzer. If the pickup arm or pickup arm motor malfunctions, the analyzer will cease to function and result in an inability to test patient samples. This may cause a delay in testing and reporting patient results. Tosoh has received fifty-one (51) complaints related to this issue with no serious injuries reported.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Tosoh Bioscience has become aware of a potential issue with the pickup arm and pickup arm motor on the AIA-900 Analyzer. If the pickup arm or pickup arm motor malfunctions, the analyzer will cease to function and result in an inability to test patient samples. This may cause a delay in testing and reporting patient results. Tosoh has received fifty-one (51) complaints related to this issue with no serious injuries reported.

Code information

All units are affected

Distribution pattern

Distributed nationwide. Foreign distribution to Canada and Latin America.