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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95285

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

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Event summary

Timeline bucket
July 31, 2024
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

IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610 IGM reagent, when used in conjunction with IMMAGE Immunochemistry Systems and Calibrator 1, is intended for the quantitative determination of immunoglobulin M (IGM) in human serum by rate nephelometry.

Z-0118-2025
Recall number
Z-0118-2025
Initiated
July 31, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Beckman Coulter Inc.
Quantity
12,102 reagents

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm identified two lots of reagents that are not meeting the sensitivity statement in the IFU

Code information

Catalog Number: 447610 UDI-DI code: 15099590221195 Lot Numbers: M307362 M309410

Distribution pattern

U.S.: AZ, CA, CO, FL, GA, HI, IL, MA, MI, MO, ND, NY, OH, PA, and TX O.U.S.: Australia, Belgium, Brazil, Chile, China, Czechia, Ecuador, France, Germany, Greece, Hong Kong, India, Italy, Kuwait, Mexico, Philippines, Poland, Portugal, Saudi Arabia, Slovakia, Spain, Sweden, Taiwan Province of China, and Turkey,