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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73433

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

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Event summary

Timeline bucket
February 24, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Ab Sciex

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

Analyst¿ MD Version 1.6.1 and 1.6.2 Software used with the following instruments: API 3200MD" LC/MS/MS System, Instrument Part Number: 5024501; 3200MD QTRAP¿ LC/MS/MS System, Instrument Part Number: 5024500; Triple Quad" 4500MD LC/MS/MS System, Instrument Part Number: 5031257; QTRAP¿ 4500MD LC/MS/MS System, Instrument Part Number: 5031231 3200MD series and 4500MD series are mass spectrometers intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass. It is intended for in vitro diagnostic purposes. For in vitro diagnostic use.

Z-1586-2016
Recall number
Z-1586-2016
Initiated
February 24, 2016
Classification
Class II
Status
Terminated
Recalling firm
Ab Sciex
Quantity
279

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Wrong quantitative results may be displayed in a report from the device, which may potentially lead to an incorrect patient diagnosis.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Wrong quantitative results may be displayed in a report from the device, which may potentially lead to an incorrect patient diagnosis.

Code information

Software Versions: Version 1.6.1 and 1.6.2

Distribution pattern

Worldwide Distribution - US (Nationwide) and Internationally to the following countries: AUSTRIA CANADA CHINA FRANCE GERMANY INDIA IRELAND ITALY KOREA MALAYSIA NETHERLANDS NORWAY RUSSIA SINGAPORE SPAIN SWITZERLAND UNITED KINGDOM

Field note

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