Exact FDA event identifier

Event 98562

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

Open FDA event record

Event summary

Timeline bucket: September 08, 2025
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 Neg Multidrug Resistant MIC 1 REF C32368 UDI-DI code: 15099590720568 Intended Use- For use with MicroScan Dried Gram Negative MIC/Combo Panels and Dried Gram Negative Breakpoint Combo Panels. MicroScan panels are designed for use in determining antimicrobial agent susceptibility and/or identification to the species level of aerobic and facultatively anaerobic gram-negative bacilli.

Z-1794-2026

Recall number: Z-1794-2026
Initiated: September 08, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Beckman Coulter, Inc.
Quantity: 3 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test.

Code information

Catalog Number: C32368 UDI-DI code: 15099590720568 Lot Number: 2026-05-08

Distribution pattern

International distribution to the country of Poland.