Exact FDA event identifier

Event 97106

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

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Event summary

Timeline bucket: May 30, 2025
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Bio-Rad Laboratories, 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

Platelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a semi-quantitative immunocapture enzyme immunoassay kit for the detection of IgM antibodies to Toxoplasma gondii in human serum, plasma or cord blood specimens.

Z-2515-2025

Recall number: Z-2515-2025
Initiated: May 30, 2025
Classification: Class II
Status: Ongoing
Recalling firm: Bio-Rad Laboratories, Inc.
Quantity: 35 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Due to a risk of false positive results that could lead to unnecessary medical treatment.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

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Inspect official wording and provenance

Reason for recall

Due to a risk of false positive results that could lead to unnecessary medical treatment.

Code information

Catalog Number: 26211 UDI-DI code: 03610520005552 Batch/Lot Number: 4L0054

Distribution pattern

U.S. Nationwide distribution in the states of CA, CO, FL, NC and NV.