Exact FDA event identifier

Event 88844

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

Open FDA event record

Event summary

Timeline bucket: September 30, 2021
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: bioMerieux, 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

API 50 CH, Model 50300

Z-0243-2022

Recall number: Z-0243-2022
Initiated: September 30, 2021
Classification: Class II
Status: Terminated
Recalling firm: bioMerieux, Inc.
Quantity: 1382 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

There is potential to provide an incorrect organism identification.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is potential to provide an incorrect organism identification.

Code information

Model 50300, Lot 1008679230 UDI: (01)03573026087401 (17)220330 (10)1008679230

Distribution pattern

Distribution in WI, NY, and SD