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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95407

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

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Event summary

Timeline bucket
September 05, 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

Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168. The Access Thyroglobulin Antibody II (TgAb) assay is used for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems.

Z-0265-2025
Recall number
Z-0265-2025
Initiated
September 05, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Beckman Coulter, Inc.
Quantity
465,481 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
IFUs for the device incorrectly states the biotin interference was remediated. The issue could result in potentially false-low results.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

IFUs for the device incorrectly states the biotin interference was remediated. The issue could result in potentially false-low results.

Code information

All IFU Part Numbers B14994, B63978, and A38168 affect all product/lots shipped from Jul-2021 to current; UDI-DI 15099590202910.

Distribution pattern

Distribution was made nationwide to the U.S., including Puerto Rico. There was government distribution but no military distribution. Foreign distribution was made to Mexico.