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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85074

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

Open FDA event record

Event summary

Timeline bucket
April 03, 2019
Product types
Device
Classifications
Class II
Statuses
Completed
Recalling firm wording
Bio-Rad Labs

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

Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test; Material Number 425-2260; Lot number 18200A - Product Usage: The assay is an aid in the diagnosis of celiac disease (gluten-sensitive enteropathy) and should be used in conjunction with other serological tests and clinical findings.

Z-1800-2020
Recall number
Z-1800-2020
Initiated
April 03, 2019
Classification
Class II
Status
Completed
Recalling firm
Bio-Rad Labs
Quantity
376 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
An elevated lot-to-lot bias was observed for Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA when compared to a previous lot of product. The observed elevated bias between these two lots is largely due to samples with higher levels of antibodies. With the cut-off for the assay being 15 U/mL, the clinical classifications for most samples would remain unchanged.

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.

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Inspect official wording and provenance

Reason for recall

An elevated lot-to-lot bias was observed for Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA when compared to a previous lot of product. The observed elevated bias between these two lots is largely due to samples with higher levels of antibodies. With the cut-off for the assay being 15 U/mL, the clinical classifications for most samples would remain unchanged.

Code information

Catalog Number 425-2260; Lot Number 18200A: UDI 00847817018336.

Distribution pattern

US Nationwide distribution including the states of AZ, NY, LA, FL, CA, TX, IA, MS, UT, and IL.