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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69791

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

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Event summary

Timeline bucket
November 06, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
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

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

VITROS CHEMISTRY PRODUCTS TRIG Slides, REF 133 6544, IVD For in vitro diagnostic use only. VITROS Chemistry Products TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System.

Z-0848-2015
Recall number
Z-0848-2015
Initiated
November 06, 2014
Classification
Class II
Status
Terminated
Quantity
USA: 380 units, Foreign: 155 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for biased results using the specific lot of VITROS CHEMISTRY PRODUCTS TRIG slides.

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

Potential for biased results using the specific lot of VITROS CHEMISTRY PRODUCTS TRIG slides.

Code information

Lot 0704-3318-4774 (expiry date 01 Dec 2015)

Distribution pattern

Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.