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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88949

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

Open FDA event record

Event summary

Timeline bucket
October 18, 2021
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
DRG International, 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

Total Thyroxine (T4) ELISA; REF EIA-1781

Z-0310-2022
Recall number
Z-0310-2022
Initiated
October 18, 2021
Classification
Class II
Status
Ongoing
Recalling firm
DRG International, Inc.
Quantity
314 total (270 US)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm has identified two lots of product that do not meet product shelf life, resulting in failed Controls. The clinical impact may be a delay in diagnosis and a consumption of patient samples.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm has identified two lots of product that do not meet product shelf life, resulting in failed Controls. The clinical impact may be a delay in diagnosis and a consumption of patient samples.

Code information

lot#: RN-60923 expiration date 12/31/2021; RN-60831 expiration date 12/31/2021

Distribution pattern

Domestic: NY; International: TZ, VN, BD, CO, TT, YE, BO, DE, SV, GE, PY, TG, RU/UA, NI, DO, NG, EG & CM