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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98754

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

Open FDA event record

Event summary

Timeline bucket
April 01, 2026
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Aniara Diagnostica LLC

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

ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A

Z-2171-2026
Recall number
Z-2171-2026
Initiated
April 01, 2026
Classification
Class II
Status
Ongoing
Recalling firm
Aniara Diagnostica LLC
Quantity
359 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.

Code information

UDI-DI: 03663537018763; Lot Number: FD1265

Distribution pattern

US Nationwide distribution in the states of CA, GA, MN, MO, NC, NM, NY, VA, WA, and WI