Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83607

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

Open FDA event record

Event summary

Timeline bucket
January 18, 2016
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Vital Scientific N.V.

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

V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.

Z-2558-2019
Recall number
Z-2558-2019
Initiated
January 18, 2016
Classification
Class II
Status
Ongoing
Recalling firm
Vital Scientific N.V.
Quantity
2

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Instrument stopped working due to a software lockup, and no patient results are produced.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Manufacturing/Software Deployment

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Instrument stopped working due to a software lockup, and no patient results are produced.

Code information

Serial #s: 13-3341 and 13-3344

Distribution pattern

US in the state of New York.