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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83582

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

Open FDA event record

Event summary

Timeline bucket
January 10, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
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

5 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 5

Viva - JR, catalog # 6002-940, UDI # 03661540600210 Product Usage: automated chemistry analyzer intended for clinical use

Z-0154-2020
Recall number
Z-0154-2020
Initiated
January 10, 2012
Classification
Class II
Status
Terminated
Recalling firm
Vital Scientific N.V.
Quantity
4 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.

Code information

serial numbers: 11-1302, 11-303, 11-304 , 11-1305

Distribution pattern

US Nationwide in the states of NY, and UT

device · product 2 of 5

Viva-E, Catalog # 6002-380, UDI # 03661540600050 Product Usage: automated chemistry analyzer intended for clinical use

Z-0155-2020
Recall number
Z-0155-2020
Initiated
January 10, 2012
Classification
Class II
Status
Terminated
Recalling firm
Vital Scientific N.V.
Quantity
75 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.

Code information

serial numbers: 10-4582 till 10-4584; 10-4586 till 10-4594; 11-2309; 11-2320 t through 11-2328; 11-2330 through-2334; 11-2336 through 11-2375; 11-2383; 11-2384; 11-2388; 11-2395; 12-2314; 12-2315; 12-2324 12-2325.

Distribution pattern

US Nationwide in the states of NY, and UT

device · product 3 of 5

V-Twin, Catalog # 6002-800, UDI # 03661540600180 Product Usage: automated chemistry analyzer intended for clinical use

Z-0156-2020
Recall number
Z-0156-2020
Initiated
January 10, 2012
Classification
Class II
Status
Terminated
Recalling firm
Vital Scientific N.V.
Quantity
39 instruments

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.

Code information

serial numbers: 10-3331; 10-3332; 11-3301; 11-3304 through 11-3306; 11-3308 through 11-3312; 11-3315; 11-3316; 11-3318 through 11-3342; 12-3302.

Distribution pattern

US Nationwide in the states of NY, and UT

device · product 4 of 5

Selectra ProM Analyzer, Catalog # 6003-435/UDI # 03661540600395 and Catalog # 6003-436/UDI # 03661540600401 Product Usage: :clinical chemistry system intended for use in clinical laboratories.

Z-0157-2020
Recall number
Z-0157-2020
Initiated
January 10, 2012
Classification
Class II
Status
Terminated
Recalling firm
Vital Scientific N.V.
Quantity
5 instruments

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.

Code information

serial numbers: 11-7425; 11-7516; 11-7535; 11-7563; 11-7564.

Distribution pattern

US Nationwide in the states of NY, and UT

device · product 5 of 5

Selectra ProS Analyzer, Catalog # 6003-600/UDI # 03661540600418 Product Usage: :clinical chemistry system intended for use in clinical laboratories.

Z-0158-2020
Recall number
Z-0158-2020
Initiated
January 10, 2012
Classification
Class II
Status
Terminated
Recalling firm
Vital Scientific N.V.
Quantity
6 instruments

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.

Code information

serial numbers: 11-9609; 11-9690; 11-9694; 11-9695; 12-9618; 12-9620.

Distribution pattern

US Nationwide in the states of NY, and UT