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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90941

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

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Event summary

Timeline bucket
October 03, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Beckman Coulter, 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

MicroScan autoSCAN-4 Instrument, Catalog Number B1018-280

Z-0269-2023
Recall number
Z-0269-2023
Initiated
October 03, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Beckman Coulter, Inc.
Quantity
53 plates

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to MicroScan autoSCAN-4 Instruments being manufactured with an incorrect diffuser plate.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to MicroScan autoSCAN-4 Instruments being manufactured with an incorrect diffuser plate.

Code information

MicroScan autoSCAN-4 Instrument Catalog Number: B1018-280 UDI-DI Code: 15099590658625 Serial Numbers for new manufactured: 400495, 400496, 400497, 400498, 400499, 400500, 400503, 400504, 400506, 400507, 400508, 400509 400510, 400511, 400512, 400513, 400514, 400515, 400516, 400517, 400518, 400519, 400520, 400521 400522, 400523, 400524, 400528 Diffuser Plate component Part Number: P/N 5639-0001 Serial Numbers for previously install base: 6685, 6786, 6826, 7480, 8449, 9911, 10405, 10446, 10886, 11219, 11295, 11424, 11815, 11841, 20351, 20403, 300003, 300175, 400058, 400080, 400234, 400340, 400354, 400373, 400444

Distribution pattern

Worldwide - U.S. Nationwide distribution in the states of AK, FL, IA, ID, MI MS, MT, NC, NE, PA, SC, TX WA, WI, and WV. The countries of Chile, Germany, Indonesia, Italy, Japan, Mexico, Peru, Portugal, South Africa, Spain, United Kingdom of Great Britain and Northern Ireland, and Uruguay.