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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92662

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 05, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
ORTHO-CLINICAL DIAGNOSTICS

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

2 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 2

VITROS Immunodiagnostic Products Troponin I ES Reagent Pack

Z-2357-2023
Recall number
Z-2357-2023
Initiated
June 05, 2023
Classification
Class II
Status
Ongoing
Quantity
4,013 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.

Code information

Product Code: 6802301; UDI-DI: 10758750002504; Lot No.: 4800; Expiration Date: 10-Jun-2023.

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.

device · product 2 of 2

VITROS Immunodiagnostic Products Troponin I ES Calibrators

Z-2358-2023
Recall number
Z-2358-2023
Initiated
June 05, 2023
Classification
Class II
Status
Ongoing
Quantity
4,013 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.

Code information

Product Code: 6802302; UDI-DI: 10758750002511; Lot No.: 4800; Expiration Date: 10-Jun-2023.

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.